SIMVASTATIN

 

PRODUCT

SIMVASTATIN

BATCH NO.

20080201

QUANTITY

10KGS

Mfg. date

feb.02, 2008

expiry date

feb.01, 2010

 

test items

specifications

test results

characters

WHITE OR ALMOST WHITE CRYSTALLINE POWDER

CONFORMS

IDENTIFICATION

POSITIVE

POSITIVE

SPECIFIC ROTATION

+285o-- +298o

+292o

SOLUBILITY

SOLUBLE IN CHLOROFORM, METHANOL AND ETHANOL

CONFORMS

LOSS ON DRYING

≤0.5%

0.02%

RESIDUE ON IGNITION

≤0.1%

0.03%

HEAVY METALS

≤20PPM

CONFORMS

limit of LOVASTATIN

≤1.0%

0.15%

RELATED materials

MAJOR≤0.4%
TOTAL≤1.0%

0.11%
0.65%

ASSAY (ON DRY BASIS)

98.0-101.0%

99.2%

 

CONCLUSION: COMPLY WITh USP30.


 

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