 |
| Menge: | |
|---|---|
DY8759
81131-70-6
C23H36NaO7
Pravastatin sodium
| Index Name | Specifications |
| Description | White or yellowish white powder or crystalline powder , Hygroscopic; Freely soluble in water and in methanol , soluble in ethanol |
| Identification | A. Specific rotation: +153 - +159 B. IR Spectrum conforms to reference standard C. Na: Forms dense precipitate on cooling |
| Appearance of solution | Clear, Not more intensely colored than reference solution BY6 |
| PH (1 IN 20, 25 deg C) | 7.2 to 9.0 |
| Water | Not more than 4.0% |
| Heavy Metals | Not more than 20ppm |
| Related substances | Impurity A: Not more than 0.3% Unidentified IND. Impurity: Not more than 0.2% Total impurities: Not more than 0.6% |
| Assay | 97.5 to 101% (on dried basis) |
| Index Name | Specifications |
| Description | White or yellowish white powder or crystalline powder , Hygroscopic; Freely soluble in water and in methanol , soluble in ethanol |
| Identification | A. Specific rotation: +153 - +159 B. IR Spectrum conforms to reference standard C. Na: Forms dense precipitate on cooling |
| Appearance of solution | Clear, Not more intensely colored than reference solution BY6 |
| PH (1 IN 20, 25 deg C) | 7.2 to 9.0 |
| Water | Not more than 4.0% |
| Heavy Metals | Not more than 20ppm |
| Related substances | Impurity A: Not more than 0.3% Unidentified IND. Impurity: Not more than 0.2% Total impurities: Not more than 0.6% |
| Assay | 97.5 to 101% (on dried basis) |