Amlodipine Amlodipine Besylate Amlodipine Besylate powder
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
ITEM |
SPECIFICATIONS |
RESULTS |
DESCRIPTION |
Appearance:White or almost white powder. Solubility: slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol |
White powder
Conforms |
IDENTIFICATION |
Infrared spectrum corresponds to that of EP RS |
Conforms |
OPTICAL ROTATION |
-0.10°~+0.10° |
0.00° |
Water |
≤0.5% |
0.11% |
Residue on Ignition |
≤0.2% |
0.05% |
Heavy metals |
≤0.002% |
Conforms |
Related substances |
Impurity D: NMT 0.3% Impurity A: NMT 0.15% Impurity E: NMT 0.15% Impurity F: NMT 0.15% Any unspecified impurity: NMT 0.1%
Total impurities: NMT 0.8% |
Impurity D: 0.005% Impurity A: N/D Impurity E: N/D Impurity F: 0.03% Largest unknown impurity: 0.007% Total impurities: 0.06% |
Assay |
97.0%~102.0%(anhydrous substance) |
99.9% |
Residual Solvent |
Ethanol≤2000 ppm |
400ppm |
Conclusion: Quality comply with EP7.4 |
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