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Atorvastatin calcium (CSA No 134523-03-8) is marketed under the trade name Lipitor among others, is a member of the drug class known as statins, which are used primarily as a lipid-lowering agent and for prevention of events associated with cardiovascular disease. Like all statins, atorvastatin works by inhibiting HMG-CoA reductase, an enzyme found in liver tissue that plays a key role in production of cholesterol in the body.
Atorvastatin was first made in August 1985 at Warner-Lambert's Parke-Davis research facility in Ann Arbor, Michigan by a team led by Bruce Roth. From 1996 to 2012 under the trade name Lipitor, atorvastatin became the world's best-selling drug to that point, with more than US$125 billion in sales over approximately 14.5 years. In the UK atorvastatin costs about 2 pounds per month as of 2016.
Specification
Appearance White or almost white powder
Identification IR, calcium
WATER 3.5-5.5%
Heavy metals NMT20ppm
Assay 98.0%-102%(calculated to anhydrous substances)
Enantiomer atorvastatin calcium NMT0.3%
Impurity A NMT0.3%
Impurity B NMT0.3%
Impurity C NMT0.3%
Impurity D NMT0.1%
Unspecfied impurity NMT0.1%
Total NMT1.0%
Ethanol NMT5000ppm
Toluene NMT890ppm
Hexane NMT290ppm
Total aerobic miorobial count NMT1000CFU/g
Total combined mold and yeast count NMT100CFU/g
Eschericha coli Negative
Application
Atorvastatin Calcium, used for lowering blood cholesterol. It also stabilizes plaque and prevents strokes through anti-inflammation and other mechanisms. Like all statins, atorvastatin works by inhibiting HMG-CoA reductase, an enzyme found in liver tissue that plays a key role in production of cholesterol in the body.
Packing&Storage
25 kg/drum.
Stored in dry and cool place.
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