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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
Rosuvastatin Calcium
CAS No.
147098-20-2
Molecular Formula
C44H54CaF2N6O12S2
Molecular Weight
1001.14
Quality Standard
97% up by HPLC, GMP,DMF,CEP, EP
Appearance
White or almost white powder
COA of Rosuvastatin calcium
ITEMS
SPECIFICATION
RESULT
Appearance
White or almost white hygroscopic powder
Conforms
Identity
IR: Similar to Reference Substance
Conforms
Enantiomeric purity
Conforms
It gives reaction (b) of calcium
Positive reaction
Related substance
Impurity A ≤ 0.2%
Impurity B ≤ 0.5%
Impurity C ≤ 0.8%
Unknown impurity ≤ 0.1%
Total impurity ≤ 1.2%
Undetected
Undetected
Undetected
Undetected
Undetected
Enantiomer
Impurity G ≤ 0.10%
Undetected
Water
≤ 0.60%
1.2%
Assay
97.0～102.0%(anhydrous substance )
99.9%
Conclusion
The results above meet all requirements under EP8.4
Usage
Function of Rosuvastatin calcium
Rosuvastatin calcium is an anti-hyperlipidemia drug which belongs to the inhibitor of HMG-CoA reductase successfully. It is suitable for the treatment of various lipid abnormalities, including hypercholesterolemia, mixed lipid qualitative abnormalities and simple hypertriglyceridemia. Rosuvastatin calcium is listed as the strongest and the most comprehensive statins drugs which has entered into market for lipid-lowering and adjustment. Compared with atorvastatin which is currently recognized with the world's best efficacy, it has a better effect of lowering the level of LDL cholesterol and increasing the level of high-density lipoprotein. Moreover, it has a better tolerance, lower side effects and unique pharmacokinetic characteristics with the half-life about 20h. It only needs to be taken once a day.
Twenty years of qualification
Audited Supplier
Pharma Sources Insight JANUARY 2024
