L-Arginina clorhidrato 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
Proveedor: Avantor Performance Materials
MACR4922-09EA
0
EUR
MACR4922-09
MACR4922-06
MACR4922-07
L-Arginina clorhidrato 98.5-101.0% USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L-Arginine hydrochloride
|
Formula:
C₆H₁₅ClN₄O₂ Pto. de fusión: 218 °C Densidad: 1,42 g/cm³ (20 °C) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00064550 Núm. CAS: 1119-34-2 |
Resultados test especificaciones
| 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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