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Aminosäuren

Bausteine des Lebens

Aminosäuren sind an fast allen Stoffwechselprozessen im Körper beteiligt. Gerade deshalb tragen sie als Bestandteil zahlreicher pharmazeutischer und diätetischer Produkte sowie in der klinischen Ernährung zur Wiederherstellung und zum Erhalt der Gesundheit und des Wohlbefindens der Menschen bei.

Wir von AMINO sorgen seit über 50 Jahren für Wirksamkeit und höchste Reinheit dieser pharmazeutischen Wirk- und Nährstoffe. An unserem Standort in Frellstedt produzieren wir Aminosäuren und andere Inhaltsstoffe biologischen Ursprungs – für Kunden in der ganzen Welt.

Lesen Sie mehr über höchste Qualitätsstandards, modernste Technologien und das attraktive Produktsortiment von AMINO!

Übersicht

Alle anzeigen
Alle ausblenden
Aminosäuren
  • DL-Asparaginsäure
    • EP 9 infusion grade
    • EP 9 oral grade
  • DL-Serin
    • EP 9 oral grade
    • USP 39 oral grade
  • Glycin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Alanin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Asparagin Anhydrid
    • EP 9 infusion grade
    • EP 9 oral grade
  • L-Asparagin Monohydrat
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / NF 34 oral grade
    • NF 34 oral grade
  • L-Asparaginsäure
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 38 oral grade
    • USP 38 oral grade
  • L-Cystin
    • EP 8 infusion grade
    • EP 8 oral grade
  • L-Glutaminsäure
    • EP 9 infusion grade
    • EP 9 oral grade
  • L-Glutamin
    • USP 39 oral grade
  • L-Histidin
    • EP 9 infusion grade
    • EP 9 oral grade
  • L-Isoleucin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Leucin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Methionin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Phenylalanin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Serin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Threonin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Tryptophan
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Tyrosin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Valin
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 38 oral grade
    • USP 38 oral grade
  • N-Acetyl-L-Methionin
    • Oral grade
  • N-Acetyl-L-Tyrosin
    • EP 9 infusion grade
    • EP 9 oral grade
Betain (Trimethylglycin)
  • Betain Anhydrid
    • Pharmaceutical oral grade
Weitere aktive pharmazeutische Wirkstoffe (APIs)
  • L-Äpfelsäure
    • EP 9 infusion grade
    • EP 9 oral grade
Aminosäuren
DL-Serine
Allgemeines
DL-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
302-84-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
USP 39 oral grade
(DL-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity
passes
Specific optical rotation (on dry basis) (10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
–0.5° to +0.5°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Organic volatile impurities
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Allgemeines
DL-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
302-84-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 oral grade
(DL-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation/ B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
–0.5° to +0.5°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Glycine
Allgemeines
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A, IR)
passes
Test on turbidity
(10.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in H2O)
≤ Y7
pH
(5.0 % (m/V) in H2O)
+5.9° to +6.4°
Related substances (HPLC)
• Glycine Anhydride
• Diglycine
• Triglycine
• each other impurity
• total of impurities
 
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.2 %
Other amino acids (AAA)
• individual impurity
• total of impurities
• Ammonium
 
≤ 0.10 %
≤ 1.0 %
≤ 0.02 %
Chlorides
≤ 75 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
Allgemeines
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity
passes
Chlorides
≤ 70 ppm
Sulfate
≤ 65 ppm
Hydrolyzable substances
passes
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A. IR)
passes
Test on turbidity
(10.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in H2O)
≤ Y7
pH
(5.0 % (m/V) in H2O)
+5.9° to +6.4°
Related substances (HPLC)
• Glycine Anhydride
• Diglycine
• Triglycine
• each other impurity
• total of impurities
 
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.2 %
Other amino acids (AAA)
• individual impurity
• total of impurities
• Ammonium
 
≤ 0.10 %
≤ 1.0 %
≤ 0.02 %
Chlorides
≤ 75 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A. IR)
passes
Test on turbidity
(10.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in H2O)
≤ Y7
pH
(5.0 % (m/V) in H2O)
+5.9° to +6.4°
Related substances (HPLC)
• Glycine Anhydride
• Diglycine
• Triglycine
• each other impurity
• total of impurities
 
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.2 %
Other amino acids (AAA)
• individual impurity
• total of impurities
• Ammonium
 
≤ 0.10 %
≤ 1.0 %
≤ 0.02 %
Chlorides
≤ 70 ppm
Sulfate
≤ 65 ppm
Heavy metals (as Pb)
≤ 20 ppm
Hydrolyzable substances
passes
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Asparagine Anhydrous
Allgemeines
L-Asparagine Anhydrous
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3
CAS Number
70-47-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 infusion grade
(L-Asparagin Anhydrous)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3M HCI at 20 °C [α]D20)
+33.7° to +36.0°
Ninhydrin-positive substances (TLC)
passes
Ammonium
≤ 0.1 %
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 1.0 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
Allgemeines
L-Asparagine Anhydrous
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3
CAS Number
70-47-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 oral grade
(L-Asparagin Anhydrous)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3M HCI at 20 °C [α]D20)
+33.7° to +36.0°
Ninhydrin-positive substances (TLC)
passes
Ammonium
≤ 0.1 %
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 1.0 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
DL-Aspartic acid
Allgemeines
DL-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
617-45-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(DL-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
–0.1° to +0.1°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aeureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 8 EU/g
Allgemeines
DL-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
617-45-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(DL-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identitiy (IR / HPLC)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+0.1° to –0.1°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
L-Alanine
Allgemeines
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+13.5° to +15.5°
Ninhydrin-positive substances (AAA)
▪ Each impurity
▪ Total impurities
 
≤ 0.10 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
Allgemeines
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+13.5° to +15.5°
Ninhydrin-positive substances (AAA)
▪ Each impurity
▪ Total impurities
 
≤ 0.10 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(10.0 % (m/V) in 6 N HCI at 25 °C [α]D25)
 
+13.5° to +15.5°
+13.7° to +15.1°
Ninhydrin-positive substances (AAA)
▪ Each impurity
▪ Total impurities
 
≤ 0.10 %
≤ 0.5 %
Organic impurities (HPLC):
▪ Maleic acid
▪ Malic acid
▪ Fumaric acid
▪ Any unspecific impurity
▪ Total unspecific impurities
 
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.20 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
pH
(5.0 % (m/V) in H2O)
5.5 to 7.0
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. IR)
passes
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 6 N HCI at 25 °C [α]D25)
+13.7° to +15.1°
Organic impurities (HPLC):
▪ Maleic acid
▪ Malic acid
▪ Fumaric acid
▪ Any unspecific impurity
▪ Total unspecific impurities
 
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.20 %
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
pH
(5.0 % (m/V) in H2O)
5.5 to 7.0
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.15 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Glutamine
Allgemeines
L-Glutamine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H10N2O3
CAS Number
56-85-9
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
USP 39 oral grade
(L-Glutamine)
Parameter
Limit
Appearance:
White or nearly white crystalline powder
passes
Identity
passes
Specific optical rotation (on dry basis)
(4.0 % (m/V) in H2O at 20 °C [α]D20)
+6.3° to +7.3°
Related substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.3 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Threonine
Allgemeines
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
USP 39 oral grade
(L-Threonine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
pH-value
(5.0 % (m/V) in H2O at 25 °C)
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 25 °C [α]D25)
–29.1° to –26.7°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Threonine)
Parameter
Limit
Appearance:
White or almost white crystalline powder on colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
ph-Value
(2.5 % (m/V) in H2O at 20 °C)
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 20 °C [α]D20
–29.0° to –27.6°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
Allgemeines
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
EP 9 oral grade
(L-Threonine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Sepecific optical rotation / B. IR)
passses
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
pH-value
(2.5 % (m/V) in H2O at 20 °C)
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 20 °C [α]D20)
–29.0° to –27.6°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Threonine)
Parameter
Limit
Appearance:
White crystalline powder or colourless flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
pH-value
(2.5 % (m/V) in H2O at 20 °C)
(5.0 % (m/V) in H2O at 25 °C)
 
5.0 to 6.5
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 20 °C [α]D20)
(6.0 % (m/V) in H2O at 20 °C [α]D20)
 
–27.6° to –29.0°
–26.7° to –29.1°
Ninhydrin-positive substances (TLC)
passes
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Serine
Allgemeines
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
USP 39 oral grade
(L-Serine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 N HCI at 25 °C [α]D25
+14.0° to +15.6°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 infusion grade
(L-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
+14.0° to +16.0°
Ninhydrin-positive substance (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
Allgemeines
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 oral grade
(L-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) om H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
+14.0° to +16.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Serine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
(10.0 % (m/V) in 2 M HCI at 25 °C [α]D25)
 
+14.0° to +16.0°
+14.0° to +15.6°
Ninhydrine-positive substances (TLC)
passes
Ninhydrine-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Glutamic acid
Allgemeines
L-Glutamic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H9NO4
CAS Number
56-86-0
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Glutamic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(10.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in 1 M HCI)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
+30.5° to +32.5°
Ninhydrin-positive substances (TLC)
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
Allgemeines
L-Glutamic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H9NO4
CAS Number
56-86-0
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Glutamic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(10.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in 1 M HCI)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
+30.5° to 32.5°
Ninhydrin-positive substances (TLC)
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
N-Acetyl-L-Methionine
Allgemeines
N-Acetyl-L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C7H13NO3S
CAS Number
65-82-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
Oral grade
(N-Acetyl-L-Methionine)
Parameter
Limit
Appearance:
White crystals or white crystalline powder
passes
Identity
passes
Specific optical rotation (on dry basis)
(5.0 % (m/V) in H2O at 20 °C [α]D20)
–22.0° to –19.0°
Ninhydrin-positive substances (TLC)
≤ 0.5 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.3 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Asparagine Monohydrate
Allgemeines
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Asparagine Monohydrate)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3 M HCI at 20 °C [α]D20)
+33.7° to +36.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (HPLC):
▪ Aspartic Acid
▪ Glumatic Acid
▪ Any unspecific impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.5 %
≤ 0.05 %
≤ 0.5 %
pH
(2 % (m/V) in H2O)
4.0 to 6.0
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Ammonium
≤ 0.1 %
Iron
≤ 10 ppm
Loss on drying
10.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
Allgemeines
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / NF 34 oral grade
(L-Asparagine Monohydrate)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3 M HCI at 20 °C [&alpha]D20)
(1.0 % (m/V) in 6 M HCI at 20 °C [&alpha]D20)
 
+33.7° to +36.0°
+33.0° to +36.5°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (HPLC):
▪ Aspartic Acid
▪ Glutamic Acid
▪ Any unspecific impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.5 %
≤ 0.05 %
≤ 0.5 %
pH
(2 % (m/V) in H2O)
4.0 to 6.0
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Ammonium
≤ 0.1 %
Iron
≤ 10 ppm
Lead
≤ 5 ppm
Loss on drying
11.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Bile-tolerant gram-negative bacteria
In 1 g n.d.
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Clostridia
In 1 g n.d.
Candida albicans
In 1 g n.d.
Allgemeines
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
NF 34 oral grade
(L-Asparagine Monohydrate)
Parameter
Limit
Identitiy (Method B)
passes
Specific optical rotation (on dry basis)
(10.0 mg/ml in 6 M HCI at 20 °C [α]D20)
+33.0° to +36.5°
Ninhydrin-positive substances (TLC)
passes
Lead
≤ 5 ppm
Loss on drying
11.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.0 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Bile-tolerant gram-negative bacteria
In 1 g n.d.
Salmonella
In 1 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Clostridia
In 1 g n.d.
Candida albicans
In 1 g n.d.
Allgemeines
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Asparagine Monohydrate)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3 M HCI at 20 °C [&alpha]D20)
+33.7° to +36.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (HPLC):
▪ Aspartic Acid
▪ Glutamic Acid
▪ Any unspecific impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.5 %
≤ 0.05 %
≤ 0.5 %
pH
(2 % (m/V) in H2O)
4.0 to 6.0
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Ammonium
≤ 0.1 %
Iron
≤ 10 ppm
Loss on drying
10.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
L-Aspartic acid
Allgemeines
L-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) n 25 % HCI at 20 °C [α]D20)
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (AAA):
▪ Asparagine
▪ Any other amino acid
▪ Sum of other amino acids
 
≤ 0.1 %
≤ 0.05 %
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
Allgemeines
L-Aspartic acid
Stability

Product is table for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 38 oral grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White powder or colourless crystals
passes
Identity (A. IR)
passes
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 6 N HCI at 20 °C [α]D20)
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
▪ of any individual impurity
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (AAA):
▪ Asparagine
▪ Any other amino acid
▪ Sum of other amino acids
 
≤ 0.1 %
≤ 0.05 %
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 38 oral grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(8.0 % (m/V) in 6 N HCI at 20 °C [α]D20)
 
+24.0° to +26.0°
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (AAA):
▪ Asparagine
▪ Any other amino acid
▪ Sum of other amino acids
 
≤ 0.1 %
≤ 0.05 %
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5%
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Tryptophan
Allgemeines
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or almost white crystalline or amorphous powder
passes
Identity
passes
Test on turbidity
(1.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(1.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)(1.0 % (m/V) in H2O at 20 °C [α]D20)
–33.0° to –30.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Related substances (HPLC)
▪ Sum of peaks with RT < Trp
▪ Sum of peaks with RT > Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
Allgemeines
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or yellowish-white crystalline powder or colourless crystals
passes
Identity
passes
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 25 °C [α]D25
–32.8° to –29.4°
Related substances (HPLC)
▪ Total impurities eluting prior Trp
▪ Total impurities eluting after Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or almost white crystalline or amorphous powder
passes
Identity
passes
Test on turbidity
(1.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(1.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
–33.0° to –30.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Related substances (HPLC)
▪ Sum of peaks eluting prior to Trp
▪ Sum of peaks eluting after Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or almost white crystalline or amorphous powder
passes
Identity
passes
Test on turbidity
(1.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(1.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
(1.0 % (m/V) in H2O at 25 °C [α]D25)
 
–33.0° to –30.0°
–32.8° to –29.4°
Ninhydrin-positive substances (TLC)
passes
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Related substances (HPLC)
▪ Sum of peaks eluting prior to Trp
▪ Sum of peaks eluting after Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Isoleucine
Allgemeines
L-Isoleucine
Stability

Products is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+40.0° to +43.0°
Ninhydrin-positive substances (HPLC)
▪ L-Leucine
▪ L-Valine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.3 %
≤ 0.3 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Isoleucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
pH
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
+38.9° to +41.8°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.3 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Isoleucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+40.0° to 43.0°
Ninhydrin-positive substances (HPLC)
▪ L-Leucine
▪ L-Valine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.3 %
≤ 0.3 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
Allgemeines
L-Isoleucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
 
+40.0° to +43.0°
+38.9° to +41.8°
Ninhydrin-positive substances (HPLC)
▪ L-Leucine
▪ L-Valine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.3 %
≤ 0.3 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
N-Acetyl-L-Tyrosine
Allgemeines
N-Acetyl-L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H13NO4
CAS Number
537-55-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(N-Acetyl-L-Tyrosine)
Parameter
Limit
Appearance:
White crystalline powder or colourless crystals
passes
Identity
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
+46.0° to +49.0°
Related substances (HPLC)
▪ Impurity A (Tyrosine)
▪ Unspecific impurities
▪ Total impurities
 
≤ 0.8 %
≤ 0.10 %
≤ 1.00 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
N-Acetyl-L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H13NO4
CAS Number
537-55-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(N-Acetyl-L-Tyrosine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
+46.0° to + 49.0°
Related substances (HPLC)
▪ Impurity A (Tyrosine)
▪ Unspecific impurities
▪ Total impurities
 
≤ 0.8 %
≤ 0.10 %
≤ 1.00 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 25 IU/g
L-Cystine
Allgemeines
L-Cystine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H12N2O4S2
CAS Number
56-89-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 8 oral grade
(L-Cystine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A and B)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ Y7
Specific optical rotation (on dry basis)
(2.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
–224.0 to –218.0°
Ninhydrin-positive substances (TLC)
≤ 0.2 %
Ninhydrin-positive substances (HPLC)
▪ Any other impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Cystine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H12N2O4S2
CAS Number
56-89-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 8 infusion grade
(L-Cystine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A and B)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ Y7
Specific optical rotation (on dry basis)
(2.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
–224.0° to –218.0°
Ninhydrin-positive substances (TLC)
≤ 0.2 %
Ninhydrin-positive substances (HPLC)
▪ Any other impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
L-Methionine
Allgemeines
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
PE
Inner liner
PE
USP 39 oral grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % (m/V) in 6 N HCI at 25 °C [α]D25)
+22.4° to +24.7°
Ninhydrin-positive substances (TLC)
▪ Each
▪ total
 
≤ 0.5 %
≤ 2.0 %
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
pH (1.0 % (m/V) in H2O)
5.6 to 6.1
Loss on drying
≤ 0.3 %
Sulphates ash
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.05 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % in 25 % HCI at 20 °C [α]D20)
+22.5° to +24.0°
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Related substances (HPLC)
▪ Unspecific impurities
▪ Total
▪ Phenylalanine
 
≤ 0.10 %
≤ 0.3 %
≤ 0.20 %
O-Acetyl-L-homoserine (AAA)
≤ 0.20 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
pH (2.5 % (m/V) in H2O)
5.5 to 6.5
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
Allgemeines
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % in 25 % HCI at 20 °C [α]D20)
+22.5° to +24.0°
Test on turbidity
(2.5% (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Related substances (HPLC)
▪ Unspecific impurities
▪ Total
▪ Phenylalanine
 
≤ 0.10 %
≤ 0.3 %
≤ 0.20 %
O-Acetyl-L-homoserine (AAA)
≤ 0.20 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
pH (2.5 % (m/V) in H2O)
5.5 to 6.5
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % in 25 % HCI at 20 °C [α]D20
+22.5° to +24.0°
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Ninhydrin-positive substances (TLC)
▪ Each
▪ total
 
≤ 0.5 %
≤ 2.0 %
Related substances (HPLC)
▪ Unspecific impurities
▪ Total
▪ Phenylalanine
 
≤ 0.10 %
≤ 0.3 %
≤ 0.20 %
O-Acetyl-L-homoserine (AAA)
≤ 0.20 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
pH-value
(2.5 % (m/V) in H2O)
(1.0 % (m/V) in H2O)
 
5.5 to 6.5
5.6 to 6.1
Loss on drying
≤ 0.3 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Leucine
Allgemeines
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Leucine)
Parameter
Limit
Appearance:
White or almost white crystalline poweder or shiny flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
 
+14.5° to +16.5°
+14.9° to +17.3°
Ninhydrin-positive substances (TLC)
passes
Related substances (AAA)
▪ L-Isoleucine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.8 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner
LDPE
EP 9 infusion grade
(L-Leucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+14.5° to +16.5°
Related substances (AAA)
▪ L-Isoleucine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.8 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
Allgemeines
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Leucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+14.5° to +16.5°
Related substances (AAA)
▪ L-Isoleucine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.8 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Leucine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
pH
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
+14.9° to +17.3°
Ninhydrin-positive substances
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.5%
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Histidine
Allgemeines
L-Histidine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H9N3O2
CAS Number
71-00-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Histidine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY7
Specific optical rotation (on dry basis)
(dissolve 2.75 g in 12.0 mL 25 % [m/V] HCI and dilute to 25.0 mL H2O, at 20 °C [α]D20)
+11.4° to +12.4°
Ninhydrin-positive substances (AAA)
▪ Any other impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
Allgemeines
L-Histidine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H9N3O2
CAS Number
71-00-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Histidine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY7
Specific optical rotation (on dry basis)
(dissolve 2.75 g in 12.0 mL 25 % [m/V] HCI and dilute to 25.0 mL with H2O, at 20 °C [α]D20)
+11.4° to +12.4°
Ninhydrin-positive substances (AAA)
▪ Any other impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Phenylalanine
Allgemeines
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny white flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
–35.5° to –33.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (KTM-Assay)
< 6 EU/g
Allgemeines
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packing.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny white flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
–35.5° to –33.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Allgemeines
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny white flakes
passes
Identity
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.4 to 6.0
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
 
–35.5° to –33.0°
–34.7° to –32.7°
Ninhydrin-positive substances (TLC)
passes
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Allgemeines
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny, white flakes
passes
Identity
passes
pH-value
(1.0 % (m/V) in 1 H2O at 25 °C)
5.4 to 6.0
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 25 °C [α]D25)
–34.7° to –32.7°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Tyrosine
Allgemeines
L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO3
CAS Number
60-18-4
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Tyrosine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
{2.5 % (m/V) in 7 % HCI)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in 7 % HCI)
≤ Y7
Specific optical rotation (on dry basis)
(5.0 % (m/V) in 3.5 % HCI at 20 °C [α]D20)
–12.3° to –11.0°
Ninhydrin-positive substances (HPLC)
▪ L-Phenylalanine
▪ Each impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.2 %
≤ 0.6 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (KTM-assay)
< 6 EU/g
Allgemeines
L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data