L(+)-Arginin 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
Leverandør: Avantor Performance Materials
MACR4926-06EA
0
NOK
MACR4926-06
MACR4926-07
MACR4926-09
L(+)-Arginin 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L(+)-Arginine
Formel:
C₆H₁₄N₄O₂ Kokepunkt: 368 °C Smeltepunkt: 238 °C Tetthet: 1,3 g/cm³ (20 °C) Lagringstemperatur: Romtemperatur |
MDL nummer:
MFCD00002635 CAS-nummer: 74-79-3 EINECS: 200-811-1 |
Spesifikasjon Testresultater
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 (C6Hl4N402) (dried basis) | 98.5 - 101.5% |
USP - Identification | Passes Test |
USP - Specific Rotation (A]25 AO (+) | 26.3 - 27.7° |
USP - Loss on Orying at 105 °C | ≤0.5% |
USP - Chloride (Cl) | ≤0.05% |
USP - Residue on Ignition | ≤0.3% |
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 (C6Hl4N402) (dried basis) | 98.5 - 101.0% |
EP/BP - Identification A | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Specific Rotation (A]2°AO (+) | 25.5 - 28.5 ° |
EP/BP-Ninhydrin-Positive Substances-Each | ≤0.2% |
EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤0.5% |
EP/BP - Chloride (Cl) | ≤200ppm |
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 - Identification | Passes Test |
JP - 0ptical rotation, 20 °C (+) | 26.9 - 27.9° |
JP - pH (1:10) | 10.5 - 12.0 |
JP - Clarity and Color of Solution | Passes Test |
JP - Chloride (Cl) | ≤0.021% |
JP - Sulfate (S04) | ≤0.028% |
JP - Ammonium (NH4) | ≤0.02% |
JP - Heavy Metals (as Pb) | ≤10 ppm |
JP - Iron (Fe) | ≤10 ppm |
JP - Related Substances | Passes Test |
JP - Loss on Orying at 105 °C | ≤0.30% |
JP - Residue after Ignition | ≤0.1% |
JP - Assay (C6Hl4N402)(dried basis) | 98.5 - 101.0% |
Endotoxin Concentration, IU/mg, For Information only | |
ChP - Specific Rotation @ 20 °C | 26.9 - 27.9 |
ChP - Identification 1 (TLC) | Passes Test |
ChP - Identification 2 (IR) | Passes Test |
ChP - Alkalinity (pH) | 10.5 - 12.0 |
ChP - Transmittance of solution | 0.98 |
ChP - Chlorides | ≤0.02% |
ChP - Sulfates | ≤0.02% |
ChP - Ammonium | ≤0.02% |
ChP - Proteins | Passes Test |
ChP - 0ther amino acids (TLC)(<=0.4%, one spot only) | Passes Test |
ChP - Loss on drying @ 105 °C | ≤0.5% |
ChP - Residue on ignition | ≤0.1% |
ChP - Iron | ≤0.001% |
ChP - Heavy metals | ≤0.001% |
ChP - Arsenic | ≤0.0001% |
ChP - Assay, dried basis | 99.0 - 101.0% |
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