L(+)-Istidina monocloridrato monoidrato 98.5-101.0%, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
Fornitore: Avantor Performance Materials
Synonyms:
(S)-(+)-Istidina monocloridrato monoidrato, H-L-His-OH.HCl.H2O, (S)-(+)-Istidina HCl monoidrato
MACR4938-06EA
0
EUR
MACR4938-06
MACR4938-07
MACR4938-09
L(+)-Istidina monocloridrato monoidrato 98.5-101.0%, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L(+)-Istidina monocloridrato monoidrato
Formula:
C₆H₉N₃O₂·HCl·H₂O Peso molecolare: 209,63 g/mol Punto di fusione: 259 °C Densità: 1,485 g/cm³ (20 °C) Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00151027 CAS Number: 5934-29-2 |
Risultati del test di specificazione
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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