Celecoxib CAS NO.169590-42-5

ITEM

SPECIFICATION

Appearance:

White to off-white crystalline powder.

Solubility

Freely soluble in methanol,ethanol,acetone and dimethyl sulfoxide, practically insoluble in water.

Melting Point:

160.0~164.0°C

Identification:

A.The infrared absorption spectrum should meet with the reference spectrum

B.The retention time of sample major peak should meet with the retention time of reference substance major peak.

Water :

≤0.5%

Sulfated Ash:

≤0.2%

Residue On Ignition:

≤0.2%

Heavy Metal

≤20ppm

Fluorine:

14.2%~16.4%

Particle Size Distribution:

≥90%,between 0.8μm and 30μm

Related substances:

Any individual impurity≤0.1%

Total impurities≤0.5%

Trifluoroacetic acid:

≤0.04%

Residual Solvent:

Ethanol:≤5000ppm

Toluene: ≤890ppm

Benzene: ≤2ppm

Assay(on dried basis)

98.0% ~102.0%

Conclusion: The product conforms to EP7.0 standard.