L(+)-Histidin 98,5-101,5% (Trockenmasse) USP, Multikompendial, erfüllt die analytischen Spezifikationen von BP, Ph. Eur., Macron Fine Chemicals™
Lieferant: Avantor Performance Materials
Synonyme:
(S)-(+)-2-Amino-3-(4-imidazoyl)propansäure
, His
, L-3-Imidazol-4-ylalanin
, (2S)-(+)-Histidin
, H
, (S)-(+)-Histidin
, H-His-OH
Veränderungsmanagement-Kategorie= R
MACR4928-07EA
0
EUR
MACR4928-07
MACR4928-06
L(+)-Histidin 98,5-101,5% (Trockenmasse) USP, Multikompendial, erfüllt die analytischen Spezifikationen von BP, Ph. Eur., Macron Fine Chemicals™
L(+)-Histidin
|
Formel:
C₆H₉N₃O₂ Molecular Weight: 155,16 g/mol Schmelzpunkt: 287 °C Dichte: 1,44 g/cm³ (20 °C) Lagertemperatur: Raumtemperatur |
MDL:
MFCD00064315 CAS-Nummer: 71-00-1 |
Spezifikation Testergebnisse
| 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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