Certificate
of Analysis
Simvastatin USP24 Batch
No. : MIT
1201
Analysis No. :
105004 Mfg
Date :
Feb 26, 2001
Quantity :
5 Kg Expiry
Date : Feb, 2004
|
Item |
Specifications |
Result |
|
Appearance |
White crystalline powder |
white crystalline powder |
|
Identification |
Conforms |
Conforms |
|
Specific
rotations |
+ 285 o to +
298 o |
+ 287.4 o |
|
Limit
of Lovastatin |
1% max |
0.2% |
|
Residue
on ignition |
0.1% max |
0.02% |
|
Loss
on drying |
0.5% max. |
0.02% |
|
Heavy
metal |
10 ppm max |
< 10 ppm |
|
Related
substance |
Single impurity < 0.4% Total impurities < 1% |
Conforms Conforms |
|
Assay |
98 to 101% |
99.4% |
|
Conclusion : The
above mentioned product conforms to USP24 |
Date of analysis : Feb 26, 2001
Approved
