| SIMVASTATIN USP |
| TESTS
|
|
| Description |
A
white or almost crystalline powder |
| Identifications
a) IR Absorption
b)
UV Absorption |
a)
As per USP <197M>
b)
As per USP <197U> |
| Specific
rotation
(0.5%
solution in Acetonitrile) |
Between
+285°
and +298°
(As
per USP < 781 S> ) |
| Loss
on Drying |
Not
more than 0.5% w/w |
| Residue
in Ignition |
Not
more than 0.1% w/w |
Heavy
Metals |
Not
more than 0.002% w/w |
Chromatographic Purity Sum of all impurities |
Not
more than 1.0% |
Limit
of Lovastatin |
Not
more than 1.0% |
Assay
(on dry basis) |
Not
less than 98% and not more than 101.0% w/w of C22H38O5 |
|
Remarks:
The product complies with the prescribed standards of USP |
|
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