L (+)-Histidine-monohydroklorid-monohydrat 98.5-101.0%, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
Leverantör: Avantor Performance Materials
Synonyms:
L-Histidine monohydrochloride monohydrate, (2S)-(+)-Histidine monohydrochloride monohydrate, L-Histidine hydrochloride monohydrate, (S)-(+)-Histidine monohydrochloride monohydrate, His HCl monohydrate, H-His-OH.HCl.H2O, H-His-OH·HCl·H₂O, L-3-Imidazol-4-ylalanine monohydrochloride monohydrate, L-Histidine hydrochloride hydrate
MACR4938-06EA
0
SEK
MACR4938-06
MACR4938-07
MACR4938-09
L (+)-Histidine-monohydroklorid-monohydrat 98.5-101.0%, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L (+)-Histidine-monohydroklorid-monohydrat
|
Formel:
C₆H₉N₃O₂·HCl·H₂O MW: 209,63 g/mol Smältpunkt: 259 °C Densitet: 1,485 g/cm³ (20 °C) Storage Temperature: Omgivande |
MDL Number:
MFCD00151027 CAS nummer: 5934-29-2 |
Specifikation testresultat
| 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 | |
| EP/BP - Assay (C6H9N302 HCl) (dried basis) | 98.5 - 101.0% |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| EP/BP - Identification F | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - pH | 3.0 - 5.0 |
| EP/BP - Specific Rotation (.A]2°AO (+) | 9.2 - 10.6° |
| EP/BP-Ninhydrin-Positive Substances-Each | ≤0.2% |
| EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤0.5% |
| EP/BP - Sulfate (S04) | ≤300 ppm |
| EP/BP - Ammonium (NH4) | ≤0.02% |
| EP/BP - Iron (Fe) | ≤10 ppm |
| EP/BP - Loss on Drying at 150 °C | 7.0 - 10.0% |
| EP/BP - Ash (sulfated) | ≤0.1% |
| JP - Identification | Passes Test |
| JP - 0ptical Rotation (+) | 9.2 - 10.6 |
| JP - pH | 3.5 - 4.5 |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Sulfate (S04) | ≤0.028% |
| JP - Ammonium (NH4) | ≤0.02% |
| JP - Iron (Fe) | ≤10 ppm |
| JP - Related Substances | Passes Test |
| JP - Water | 7.2 - 10.0% |
| JP - Residue on Ignition | ≤0.10% |
| JP - Assay (anhydrous basis) | 99.0 - 101.0% |
| ChP - Specific Rotation @ 20 °C | 8.5 - 10.5° |
| ChP - Identification 1 (TLC) | Passes Test |
| ChP - Identification 2 (IR) | Passes Test |
| ChP - Acidity or alkalinity (pH) | 3.5 - 4.5 |
| ChP - Transmittance of solution | ≥ 98.0% |
| ChP - Chloride Content | 16.7 - 17.1% |
| ChP - Sulfates | ≤0.02% |
| ChP - Ammonium | ≤0.02% |
| ChP - 0ther amino acids (TLC)(<=0.2%, one spot only) | Passes Test |
| ChP - Loss on drying @ 105 °C | ≤0.2% |
| ChP - Residue on ignition | ≤0.1% |
| ChP - Heavy metals | ≤0.001% |
| ChP - Arsenic | ≤0.0001% |
| ChP - Bacterial endotoxin, EU/g | ≤6.0 |
| ChP - Assay, dried basis | 99.0 - 101.0% |
| ChP - Iron | ≤0.001% |
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