Certificate
of Analysis
Spironolactone USP24 Batch
No. :
MIT0010
Analysis No. :
01513 Mfg
Date :
Feb 20, 2001
Quantity :
30 Kg Expiry
Date : Feb, 2004
|
Item |
Specifications |
Result |
|
Appearance |
White to off-white crystalline powder |
White to off-white crystalline powder |
|
Identification |
Positive |
Positive |
|
Melting
point |
198 to 207 oC |
204 oC |
|
Specific
rotation |
-33 to -37 o |
-35.92 o |
|
Assay |
97 to 103% |
98.90% |
|
Loss
on drying |
0.5 % max. |
0.16% |
|
Related
impurities |
2% max. |
< 2% |
|
Limit
of Mercapto Compound |
0.1 ml max. |
< 0.1 ml |
|
Organic
volative Impurity |
Complies |
Complies |
|
Micronization |
Micronized |
Micronized |
|
Conclusion : The
above mentioned product conforms to USP24 |
Date of analysis : Feb 21, 2001
Approved
