We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.
One More Step to Finalize Your Registration
An activation link has been sent to your email address.
Please check the email and activate your account now. It might take few minutes to get the email.
If you did not find it, please check your spam box.
Having problem receiving the email? Send again
Still cannot receive? Contact us
Email ：PharmaSources@imsinoexpo.com
Whatsapp ：+86-13621645194
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
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.
Twenty years of qualification
Audited Supplier
Pharma Sources Insight June 2024: Globalization on the Go
