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Atorvastatin calcium 134523-03-8

Atorvastatin calcium 134523-03-8

98% up by HPLC, USP34
  • 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.

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Send A Message
Send A Message
If you are interested in our products and want to know more details,please leave a message here,we will reply you as soon as we can.

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