L(+)-Arginine 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
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MK4926-06EA
1120.89
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L(+)-Arginine 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L(+)-Arginine
|
Formula:
C₆H₁₄N₄O₂ Boiling Pt: 368 °C Melting Pt: 238 °C Density: 1.3 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00002635 CAS Number: 74-79-3 EINECS: 200-811-1 |
Specification Test Results
| 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 0nly | |
| 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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