Listing ID #7154178
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SR.NO |
TEST |
SPECIFICATION |
RESULT |
1. |
Description |
White or almost white, crystalline or amorphous powder |
Almost white, crystalline powder |
2. |
Solubility |
Soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water |
Complies |
3. |
Identification |
IR spectrum matches with that of standard |
Complies |
A By IR |
The infrared absorption spectrum of the substances should be concordant with the spectrum of celecoxib WRS/CRS. |
Complies |
|
B. By Assay (By HPLC) |
The retention time of major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
Complies |
|
4. |
Impurities |
||
1.Inorganic Impurities: |
|||
Residue on Ignition |
Not more than 0.20% w/w |
0.07% |
|
2. Organic Impurities (By HPLC) |
|||
Celecoxib related compound A |
Not more than 0.40% |
Not detected |
|
Celecoxib related compound B |
Not more than 0.10% |
0.08% |
|
Individual unspecified impurity |
Not more than 0.10% |
0.01% |
|
Total Impurities |
Not more than 0.50% |
0.09% |
|
5. |
Water determination |
Not more than 0.50% |
0.12% |
6. |
Assay (By HPLC) |
Not less than 98.0% w/w and not more than 102.0% w/w (anhydrous basis) |
99.70% |
Additional test |
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7. |
Residual solvents (By HSGC) |
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Methanol |
Not more than 3000 ppm |
257.18 ppm |
|
2- propanol |
Not more than 5000 ppm |
Not detected |
|
Methylene chloride |
Not more than 600 ppm |
Not detected |
|
Toluene |
Not more than 890 ppm |
3.63 ppm |