L-Arginin hydrochlorid 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
Dodavatel: Avantor Performance Materials
MACR4922-09EA
0
CZK
MACR4922-09
MACR4922-06
MACR4922-07
L-Arginin hydrochlorid 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L-Arginine hydrochloride
Vzorec:
C₆H₁₅ClN₄O₂ Bod tání: 218 °C Hustota: 1,42 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00064550 CAS číslo: 1119-34-2 |
Výsledky specifikačního testu
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 (C6H14N402·HCl) (dried basis) | 98.5 - 101.5% |
USP - Identification | Passes Test |
USP - Specific Rotation (A]2°AO (+) | 21.4 - 23.6° |
USP - Loss on Orying at 105 °C | ≤0.2% |
USP - Residue on Ignition | ≤0.1% |
USP - Sulfate (S04) | ≤0.03% |
USP - Related Compounds - Individual Impurities | ≤0.5% |
USP - Related Compounds - Total Impurities | ≤2.0% |
USP - Chloride (Cl) | 16.5 - 17.1% |
EP/BP - Assay (C6H14N402·HCl) (dried basis) | 98.5 - 101.0% |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification E | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Specific Rotation (A]2°AO (+) | 21.0 - 23.5° |
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 Orying | ≤0.5% |
EP/BP - Ash (sulfated) | ≤0.1% |
JP - Assay (C6H14N402·HCl) (dried basis) | 98.5 - 101.0% |
JP - Identification | Passes Test |
JP - 0ptical Rotation (+) | 21.5 - 23.5° |
JP - pH (1 in 10) | 4.7 - 6.2 |
JP - Clarity and Color of Solution | Passes Test |
JP - Sulfate (S04) | ≤0.028% |
JP - Ammonium (NH4) | ≤0.02% |
JP - Arsenic (As) | ≤2 ppm |
JP - Related Substances | Passes Test |
JP - Loss on Orying at 105 °C | ≤0.20% |
JP - Residue after Ignition | ≤0.10% |
Endotoxin Concentration, IU/mg, For Information only | |
ChP - Transmittance of solution | ≥ 98.0% |
ChP - Sulfates | ≤0.02% |
ChP - Ammonium | ≤0.02% |
ChP - Loss on drying @ 105 °C | ≤0.2% |
ChP - Residue on ignition | ≤0.1% |
ChP - Heavy metals | ≤0.001% |
ChP - Arsenic | ≤0.0001% |
ChP - Identification 1 (TLC) | Passes Test |
ChP - Identification 2 (IR) | Passes Test |
ChP - Chloride Content | 16.5 - 17.1% |
ChP - 0ther amino acids (TLC)(<=0.2%, one spot only) | Passes Test |
ChP - Proteins | Passes Test |
ChP - Iron | ≤0.001% |
ChP - Specific Rotation @ 20 °C (+) | 21.5 - 23.5 |
ChP - Phosphates | ≤0.02% |
ChP - Assay (dried basis) | 98.5 - 101.0% |
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