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Product Name: Pravastatin Sodium
CAS No.: 81131-70-6
EP 5
Pravastatin Sodium
Standard: EP5
Description: White to yellowish powder or crystalline powder
Impurity A: 0.3% Max
Unidentified individual impurity: 0.2% Max
Total impurities: 0.6% Max
Residual solvents:
Acetone: 5000ppm Max
Butyl Acetate: 5000ppm Max
Ethyl Acetate: 5000ppm Max
Identification: 1) IR spectrum conforms to reference standard
2) Positive for sodium
Specific rotation: +153°~ +159°
Appearance of solution: Clear, Color≤BY6
PH: 7.2 ~ 9.0
Water: 4.0% Max
Heavy metals: 20 ppm Max
Assay (On dry basis): 97.0 ~ 102.0%
Related compounds:
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