| Customization: | Available |
|---|---|
| CAS No.: | 147526-32-7 |
| Formula: | C50h46caf2n2o8 |
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| Product name | Pitavastatin calcium | Appearance | White powder | |
| Standard | USP/EP | Solubility | Water Soluble | |
| Formula: | C50H46CaF2N2O8 | CAS: | 147526-32-7 | |
| Tests | Results | Specifications |
| Character | Complies | White to almost white amorphous powder; odorless, tasteless; unstable to light, hygroscopic |
| Solubility | Complies | Should comply |
| Specific optical rotation | +25° | +20°~+26° |
| Specific absorbance | 960 | 960~980 |
Identification |
Complies | Chemistry reaction, should be positive reaction |
| Complies | Chemistry reaction, should be positive reaction | |
| Complies | UV spectrophotometry, should comply | |
| Complies | By IR absorption, to match with the working standard | |
| Complies | Liquid chromatogram, should comply | |
| Flu-orine | 4.1% | 4.0%~5.0%, calculated on the anhydrous basis |
Related substance |
0.1% | Epimer ≤ 0.5% |
| 0.03% | Lactone compounds ≤ 0. 1% | |
| 0. 1% | Other single impurities ≤ 0. 1% | |
| 0.4% | The sum of impurities ≤ 1.0% | |
| Enantiomer | 0.1% | the area of the enantiomer is not more than 0.5 times the principal peak area of the reference solution (0.5%). |
Residual solvent |
0.05% | Me-thanol ≤ 0.3% |
| 0 | Ethanol ≤ 0.5% | |
| 0 | Dichloro me-thane ≤ 0.06% | |
| 0 | Tetrahy drofuran ≤ 0.072% | |
| 0 | Tolu ene ≤ 0.089% | |
| Chloride | Complies | ≤ 0.06% |
Microbial limit |
< 10 cfu/g | Bacterial count: NMT 80 cfu/g |
| < 10 cfu/g | Fungus and yeast count: NMT 10 cfu/g | |
| Absent | Escherichia coli: Absent | |
| Calcium | 4.1% | 4.0%~5.0%, calculated on the anhydrous basis |
| Water | 2.1% | ≤ 3.0% |
| Heavy metals | Complies | ≤ 20ppm |
| Assay(calculated on the dried basis) | 100.2% | ≥ 98.5%(C50H46GaF2N2O8) |
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