Etodolac - IP - Kreative Organics

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	144⁰C-150⁰C
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 0.1% Total Impurity NMT 1.0%