Atorvastatin calcium
Characteristics:Awhiteoralmostwhite,powder. Identification:IRCalcium Water:3.5%~5.5%. Heavymetals:≤20ppm Assay:98.0%~10…
Characteristics: A white or almost white, powder.
Identification: IR Calcium
Water: 3.5%~5.5%.
Heavy metals: ≤ 20ppm <
Assay :98.0%~102.0%(Calculated to anhydrous substances)
Enantiomer atorvstatin calcium E : ≤ 0.3%
Related substances: Impurity A: ≤ 0.2%
Impurity B: ≤ 0.3%
Impurity C: ≤ 0.3%
Impurity D: ≤ 0.1%
Unspecified impurity: ≤ 0.1%
Total: ≤1.0%
Residual solvents: Ethanol : ≤ 5000ppm
Tothene: ≤ 890ppm
N-Hexane: ≤ 290ppm
Bioburden:
Total Aerobic microbial count: ≤ 1000CFU/g
Total combined mold and yeast count:≤
100CFU/g
Eschericha coli: Negative
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