Celecoxib Usp

SR.NOTESTSPECIFICATIONRESULT
1.DescriptionWhite or almost white, crystalline or amorphous powderAlmost white, crystalline powder
2.SolubilitySoluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in waterComplies
3.IdentificationIR spectrum matches with that of standardComplies
A By IRThe 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 IgnitionNot more than 0.20% w/w0.07%
2. Organic Impurities (By HPLC)
Celecoxib related compound ANot more than 0.40%Not detected
Celecoxib related compound BNot more than 0.10%0.08%
Individual unspecified impurityNot more than 0.10%0.01%
Total ImpuritiesNot more than 0.50%0.09%
5.Water determinationNot 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%