Seema Biotech CELECOXIB USP, Purity : 99%

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

7.

Residual solvents (By HSGC)

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