Atorvastatin calcium 134523-03-8

98% up by HPLC, USP34

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Product Details

Product Information

Product name	Atorvastatin calcium
CAS No.	134523-03-8
Molecular Formula	C66H68CaF2N4O10
Molecular Weight	1155.36
Quality Standard	98% up by HPLC
Appearance	White or almost white powder

COA of Atorvastatin calcium

ITEMS	SPECIFICATION	RESULT
Appearance	White or almost white powder	Conforms
Identification	IR Calcium	Conforms
Water	3.5%-5.5%	5.0%
Heavy metals	≤ 20 ppm	< 20 ppm
Assay	98.0%-102.0% (calculated to anhydrous substances)	99.5%
Enantiomer atorvstatin calcium E	≤ 0.3%	0.05%
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 %	0.1% 0.04% 0.04% 0.07% 0.1% 0.5%
Residual solvents	Ethanol:≤ 5000ppm Tothene:≤ 890ppm N-Hexane:≤ 290ppm	ND 158ppm ND
Bioburden (By HPLC)	Total Aerobic microbial count ≤ 1000CFU/g Total combined mold and yeast count ≤ 100CFU/g Eschericha coli: Negative	< 10 CFU/g < 80CFU/g ND
Conclusion	The result conforms with USP34

Usage

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.