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Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:99% up, USP34,GMP, DMF Atorvastatin Calcium 134523-03-8
CAS No.:134523-03-8
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co. Ltd
Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
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:≤ 5000ppmTothene:≤ 890ppmN-Hexane:≤ 290ppm |
ND158ppmND |
Bioburden(By HPLC) |
Total Aerobic microbial count ≤ 1000CFU/gTotal combined mold and yeast count ≤ 100CFU/gEschericha coli: Negative |
< 10 CFU/g< 80CFU/gND |
Conclusion |
The result conforms with USP34 |
Usage |
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