Atorvastatin calcium

Details:

1.Product description

Product Name: Atorvastatin calcium

CAS: 134523-03-8

MF: C66H68CaF2N4O10

MW: 1155.36



2.Physical properties

White or almost white powder,slightly hygroscopic, ordorless. Very solutable in acetonitrile or chloroform, Soluble in Water, very soluble and practically insolutable in ethyl ether



3.Specification

TEST

STANDARD

RESULT

Appearance:

white or almost white powder,

slightly hygroscopic, ordorless



Confirms

Very solutable in acetonitrile or chloroform, Soluble in Water, very soluble and practically insolutable in ethyl ether

Confirms

Identification

(1) IR

Conforms

(2) HPLC

Conforms

Water

NMT 5.0%

0.6%

Residue on ignition

NMT 0.2%

0.1%

Methyl benzenesulfonate

NMT 0.1%

undetected

Toluene

NMT 890ppm (ICH)

102ppm

Chromatographic purity

(1) Laudanosine: NMT 0.5%

(2) Other individual impurities: NMT 1.0%

(3) Total Impurities: NMT 3.5%

0.01%

0.38%

1.3%

Isomer Ratio

Trans-Trans Isomer: 5%-6.5%

5.7%



Cis-Trans Isomer: 34.5%-38.5%

36%



Cis-Cis Isomer: 55%-60%

58.2%

Assay

96%-102%

(C65H82N2O18S2 on anhydrous basis)

100.2%

Residue Solvents

(1) Dichloromethane: NMT 600ppm

(2) Acctonitrile: NMT 410ppm

(3) Ethyl ether: NMT 5000ppm

Undetected

Undetected

1739ppm

Result

Confirms to USP34







4.Application

Atorvastatin is a member of the drug class known as statins, used for lowering blood cholesterol. It also stabilizes plaque and prevents strokes through anti-inflammatory 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.

5.Packing

25KG/Drum or as per your requirement