SPECIFICATION OF GLIBENCLAMIDE IP/BP/EP/USP
SR. NO TEST SPECIFICATION
1 Description White to almost White Crystalline Powder
2 Solubility Practically insoluble in water, sparingly soluble in methylene chloride, slightly soluble in alcohol and in methanol.
3 Identification1. Melting Point2. By UV3. By IR4. By TLC5. Chemical test 1. Between 169 0C to 174 0C 2. The sample solution should show a maximum at 300 nm and a less intense maximum absorbance at 275 nm. The specific absorbance at the maxima should be 61 to 65 and 27 to 32 respectly.3. IR spectrum of sample should be concordant with that of glibenclamideworking standard.4. The Principal spot obtained with the test solution should be Similar in position and size to the principal spot obtained in the chromatogram obtiained with the reference solution.5. The sample solution should show blue fluorescence in ultraviolet light at 365 nm. Dislove 0.1 gm of chloral hydrate in solution, within 5 min. , the colour should change to deep yellow, and after 20 min develops a brownish tinge
4 Heavy Metal Not more then 20 ppm
5 Sulphated Ash Not more then 0.1 % w/w
6 Related Substances1. Impuriety A2. Impuriety B3. Unknown Impurity 14. Unknown Impurity 25. Unknown Impurity 36. Total of other impurities 1. Not more than 0.5 % 2. Not more than 0.5 % 3. Not more than 0.2 % 4. Not more than 0.1 % 5. Not more than 0.1 % 6. Not more than 0.5 %
7 Loss on drying Not more than 0.1 % w/w
8. Assay Not less than 99.0 % w/w and not more than equivalent of 101.0% w/w of C23H28CLN3O5S, calculated with reference to the dried substance.