L(+)-Histidine 98.5-101.5% (dried basis) USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
Supplier: Avantor Performance Materials
Synonyms:
L-3-Imidazol-4-ylalanine, (S)-(+)-Histidine, (S)-2-Amino-3-(4-imidazolyl)propionic acid, H-His-OH, NSC 137773, L-Histidine
Management of Change (MOC) category = R
MACR4928-06EA
74.4
SGD
MACR4928-06
MACR4928-07
L(+)-Histidine 98.5-101.5% (dried basis) USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L(+)-Histidine
Formula:
C₆H₉N₃O₂ MW: 155,16 g/mol Melting Pt: 287 °C Density: 1,44 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00064315 CAS Number: 71-00-1 |
Specification Test Results
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets ChP Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Meets E.P. Chemical Specifications | |
Preserve in Tight Containers | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C H N 0 ) (dried basis) | 98.5 - 101.5% |
USP - Identification | Passes Test |
USP - Specific Rotation [A)25 AO (+) | 12.6 - 1.4.0° |
USP - pH | 7.0 - 8.5 |
USP - Loss on Orying at 105 °C | ≤0.2% |
USP - Residue on Ignition | ≤0..4% |
USP - Chloride (Cl) | ≤0.05% |
USP - Sulfate (S04) | ≤0.03% |
USP - Iron (Fe) | ≤0.003% |
USP - Related Compounds - Individual Impurities | ≤0.5% |
USP - Related Compounds - Total Impurities | ≤2.0% |
EP/BP - Assay (C H N 0 ) (dried basis) | 98.5 - 101.0% |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Specific Rotation [A)2°AO (+) | 11..4 - 12..4° |
EP/BP-Ninhydrin-Positive Substances-Each | ≤0.2% |
EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤0.5% |
EP/BP - Chloride (Cl) | ≤200 ppm |
EP/BP - Sulfate (S04) | ≤300 ppm |
EP/BP - Ammonium (NH4) | ≤0.02% |
EP/BP - Iron (Fe) | ≤10 ppm |
EP/BP - Loss on Orying | ≤0.5% |
EP/BP - Ash (sulfated) | ≤0.1% |
JP - Assay (C6H9N302) (dried basis) | 99.0 - 101.0% |
JP - Ammonium (NH4) | ≤0.02% |
JP - Chloride (Cl) | ≤0.021% |
JP - Clarity and Color of Solution | Passes Test |
JP - Iron (Fe) | ≤10 ppm |
JP - Identification | Passes Test |
JP - Loss on Orying at 105 °C | ≤0.30% |
JP- 0ptical Rotation [A)2°AO (+) | 11.8 - 12.8° |
JP - Related Substances | Passes Test |
JP - pH | 7.0 - 8.5 |
JP - Residue on Ignition | ≤0.1% |
JP - Sulfate (S04) | ≤0.028% |
ChP - Assay (dried basis) | 99.0 - 101.0% |
ChP -Specific Rotation @ 20 °C (+) | 12.0 - 12.8° |
ChP - Identification 1 (TLC) | Passes Test |
ChP - Identification 2 (IR) | Passes Test |
ChP - Acidity or alkalinity (pH) | 7.0 - 8.5 |
ChP - Transmittance of solution | ≥ 98.0% |
ChP - Chlorides | ≤0.02% |
ChP - Sulfates | ≤0.02% |
ChP - Ammonium | ≤0.02% |
ChP - 0ther amino acids (TLC)(<=0.5%, one spot only) | Passes Test |
ChP - Loss on drying @ 105 °C | ≤0.2% |
ChP - Residue on ignition | ≤0.1% |
ChP - Iron | ≤0.001% |
ChP - Heavy metals | ≤0.001% |
ChP - Arsenic | ≤0.0001% |
ChP - Bacterial endotoxin, EU/g | ≤6.0 |
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