Diclofenac Sodium

Nonsteroidal anti-inflammatory drug

Parameters Results
Name Diclofenac Sodium
Quality IP/BP/EP/USP
IUPAC Name Sodium;2-[2-(2,6-dichloroanilino)phenyl]acetate
Molecular Formula C14H10Cl2NNaO2
Molecular Weight 318.1 gm/mol
CAS Number 15307-79-6
Physical Appearance White or slight yellowish, slightly hygroscopic, crystalline powder
Solubility Sparingly soluble in water, freely soluble in methanol, soluble in ethanol (96%), slightly soluble in acetone
Melting Range About 280°C with decomposition
Identification by
A) IR Absorption
B) By TLC
C) Chemical Test
D) Reaction of Sodium
Tests A, B, C and D complies
Appearance of Solution The solution shall be clear and absorbance at 440 nm is not greater than 0.05
Related Substances (By HPLC)
Impurity A
Impurity F
Unspecified Impurity
Total Impurity

Not more than 0.2%
Not more than 0.15%
Not more than 0.1%
Not more than 0.4%
Heavy Metals Not more than 10 ppm
Loss on drying Not more than 0.5% w/w
Assay (on dried basis) 99% to 101% w/w