APIs

Etodolac - EP/BP

Sl. No. Test Parameter Specification
1 Description A White or almost white, crystalline powder.
2 Solubility Water : Practically insoluble
Acetone : Freely soluble
Ethanol : Freely soluble
3 Identification
a) IR 
b) TLC
IR absorption Spectrum matches the Standard Spectrum.
TLC matches with that of the reference standard
4 Melting Range 144OC-150OC
5 Water content (KF) NMT 0.5%
6 Sulphated ash NMT 0.1%
7 Limit of chloride NMT 300 ppm
8 Assay on dry basis 98.0% - 102.0%
9 Related Substances by HPLC Impurity A NMT 0.2%
Impurity B NMT 0.2%
Impurity C NMT 0.5%
Impurity D NMT 0.2%
Impurity E NMT 0.2%
Impurity F NMT 0.2%
Impurity G NMT 0.2%
Impurity H NMT 0.2%
Impurity I NMT 0.2%
Impurity K NMT 0.2%
Unspecified Impurity NMT 0.10%
Total Impurity NMT 1.0%