Shijiazhuang Zulei commerce Co.,Ltd.
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Business Type:Manufacturer
Country/Region:China
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Amlodipine Besylate
CAS No.: 111470-99-6
Quality standard: EP6.0
Assay: >99%
Color: White crystalline powder
Melting point: 195℃~201℃
Packing: Cardboard drum
| ITEM | Test | RESULTS | |
| Appearance | White crystalline powder | Almost white powder | |
| Solubility | Slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol. | complies | |
| Identification | A.The IR spectrum should be concordant with IR spectrum of the RS B.Identity test C. Identity test | complies | |
| Optical rotation | -0.10º to + 0.10º | 0.01 º | |
| Water | Not more than 0.5% | 0.2% | |
| Residue on ignition | Not more than 0.2% | 0.1% | |
| Heavy metals | Not more than 0.002% | Less than0.002% | |
| Related substances | A. TLC - any impurity - nmt 0.3% - not more than two impurities – not more than 0.1 B. liquid chromatography - impurity D – nmt 0.3% - total impurities – nmt 0.3% | complies ND 0.28% | |
| Assay | It contains not less than 98.0% and not more than 102.0% of C26H31ClN2O8Scalculated with reference to the dried substance. | 99.3% | |
| Conclusion | Conform to EP standard | ||
