Description
| Product Name | Atorvastatin Calcium | ||
| Purity | 99%min by HPLC | CAS No. | 134523-03-8 |
| M.F. | C66H68CaF2N4O10 | M.W. | 1155.355 |
| Loss on drying | <3.0% | Standard | Factory Standard |
| Item | Specification | Result | |
| Appearance | White powder | Complies | |
| Related substance (HPLC) | Total impurity ≤0.5% | 0.20% | |
| Max single impurity ≤0.1% | 0.06% | ||
| Odor | Characteristic | Complies | |
| Assay | 99% | 99.22% | |
| Sieve analysis | 100% pass 80 mesh | Complies | |
| Heavy Metal | <10ppm | Complies | |
| As | <0.1ppm | 0.05ppm | |
| Pb | <0.1ppm | 0.05ppm | |
| Cd | <0.1ppm | 0.05ppm | |
| Residual Solvents | <100ppm | Complies | |
| Residual Pesticide | Negative | Complies | |
| Total Plate Count | <1000cfu/g | Complies | |
| Yeast & Mold | <100cfu/g | Complies | |
| E.Coli | Negative | Complies | |
| Salmonella | Negative | Complies | |
