CAS No.: | 147526-32-7 |
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Formula: | C50h46caf2n2o8 |
EINECS: | / |
Type: | Pharmaceutical Intermediates |
Appearance: | Powder |
Quality: | Refined |
Customization: |
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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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