Certificate
of Analysis
Tolmetin Sodium USP24 Batch
No. : MIT10201
Analysis No. :
001130 Mfg
Date :
Feb 5, 2001
Quantity :
500 Kg Expiry
Date : Feb, 2004
|
Item |
Specifications |
Result |
|
Appearance |
White
or slight yellowish crystalline powder |
Conforms |
|
Identification
|
Conforms to IR, UV and Sodium
Test |
Positive |
|
Loss
on drying |
10.4 – 12.4 % |
11.57% |
|
Heavy
metal |
0.002 % max. |
< 0.002% |
|
Chromatographic
purity Single
impurity Total
impurities |
0.5 % max. 2.0 % max. |
0.4 % 0.8 % |
|
Organic
volative impurities |
Meets the requirement |
Meets the requirement |
|
Assay |
98.0 – 102.0% |
100.6% |
|
Conclusion : The
above mentioned product conforms to USP24 |
Date of analysis : Feb 8, 2001
Approved
