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| 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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