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Sinoway Industrial Co.Ltd.
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Product name
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Atorvastatin calcium
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CAS No.
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134523-03-8
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Molecular Formula
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C66H68CaF2N4O10
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Molecular Weight
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1155.36
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Quality Standard
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98% up by HPLC
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Appearance
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White or almost white powder
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COA of Atorvastatin calcium
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ITEMS
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SPECIFICATION
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RESULT
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Appearance
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White or almost white powder
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Conforms
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Identification
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IR Calcium
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Conforms
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Water
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3.5%-5.5%
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5.0%
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Heavy metals
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≤ 20 ppm
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< 20 ppm
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Assay
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98.0%-102.0% (calculated to anhydrous substances)
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99.5%
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Enantiomer atorvstatin calcium E
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≤ 0.3%
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0.05%
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Related substances
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Impurity A: ≤ 0.2%
Impurity B: ≤ 0.3%
Impurity C: ≤ 0.3%
Impurity D: ≤ 0.1%
Unspecified impurity: ≤ 0.1%
Total: ≤ 1.0 %
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0.1%
0.04%
0.04%
0.07%
0.1%
0.5%
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Residual solvents
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Ethanol:≤ 5000ppm
Tothene:≤ 890ppm
N-Hexane:≤ 290ppm
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ND
158ppm
ND
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Bioburden
(By HPLC)
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Total Aerobic microbial count ≤ 1000CFU/g
Total combined mold and yeast count ≤ 100CFU/g
Eschericha coli: Negative
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< 10 CFU/g
< 80CFU/g
ND
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Conclusion
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The result conforms with USP34
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Application of Atorvastatin calcium
1. Hypercholesterolemia
patients with primary hypercholesterolemia. Including patients with familial hypercholesterolemia (heterozygous type) or mixed hyperlipidemia (equivalent to types IIa and IIb of Fredrickson classification), if the effect of dietary therapy and other non-drug treatments is not satisfactory, the application of this product can be treated It has elevated total cholesterol (TC), elevated low-density lipoprotein cholesterol (LDL-C), elevated apolipoprotein B (Apo B), and elevated triglycerides (TG).
In patients with homozygous familial hypercholesterolemia, atorvastatin can be used in combination with other lipid-lowering therapy (eg, LDL plasma dialysis) or alone (when no other therapy is available) to lower TC and LDL-C.
2. coronary heart disease
For patients with coronary heart disease or coronary heart disease equivalent risk disease (such as diabetes, symptomatic atherosclerotic disease, etc.) combined with hypercholesterolemia or mixed dyslipidemia, this product is suitable for: reducing the risk of non-fatal myocardial infarction, reducing Risk of fatal and non-fatal stroke, reduced risk of revascularization, reduced risk of hospitalization for congestive heart failure, and reduced risk of angina.
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