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Atorvastatin Calcium USP
Uses:
Atorvastatin is a statin medication used to prevent cardiovascular disease in those at high risk and treat abnormal lipid levels. For the prevention of cardiovascular disease, statins are a first-line treatment.
Identifiers
- CAS No:
- [134523-03-8]
- BRN No:
- -
- UN No:
- -
Properties
- Molecular Formula:
- (C33H35FN2O5)2Ca* 3H2O
- Molecular Weight:
- 1155.36 g/mol
Specifications
| Sr. No. | Test | Limits |
|---|---|---|
| 1 | Description | A white to off white powder. |
| 2 | Solubility | Soluble to freely soluble in Methanol, Slightly soluble in alcohol, Insoluble to Very slightly soluble in Distilled Water, pH 7.4 Phosphate buffer, and Acetonitrile, Insoluble in aqueous solutions of pH 4 and below. |
| 3 | Identification | |
| a. By FTIR | The infrared absorption spectrum of the sample should be concordant to that of the standard. |
|
| b. By AAS | The sample solution exhibits a significant absorption at the calcium emission line at 422.7nm |
|
| 4 | Water by KF (%, w/w) | Between 3.5 to 5.5 |
| 5 | Enantiomeric Purity by HPLC Related compound E (%, w/w) |
Not more than 0.3 |
| 6 | Related Substances by HPLC(%, w/w) | |
| a. Atorvastatin Diamino | Not more than 0.15 | |
| b. Atorvastatin Related compound A | Not more than 0.30 | |
| c. Atorvastatin Related compound B | Not more than 0.30 | |
| d. Atorvastatin Related compound C | Not more than 0.30 | |
| e. Atorvastatin 3-Deoxyhept-2-enoic acid | Not more than 0.10 | |
| f. Atorvastatin Related compound H | Not more than 0.15 | |
| g. Atorvastatin Epoxy tetrahydrofuran analog | Not more than 0.15 | |
| h. Atorvastatin Ethyl ester | Not more than 0.15 | |
| i. Atorvastatin Related compound D | Not more than 0.15 | |
| j. Atorvastatin Related compound I | Not more than 0.15 | |
| k. Any other individual impurity | Not more than 0.10 | |
| l. Total impurities | Not more than 1.00 (Reporting level of impurities: 0.05) |
|
| 7 | Assay by HPLC (%, |
Between 98.0 to 102.0 |
