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Glibenclamide

Product Name	Glibenclamide BP/EP/USP
Chemical Name	5-chloro-N-(4-[N-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-methoxybenzamide
CAS Number	10238-21-8
Chemical Formula	C₂₃H₂₈ClN₃O₅S
Molecular Mass	494.01 g/mol
Therapeutic Category	Antidiabetic

Specification of Glibenclamide :

Test	Specification
Description	White or almost white crystalline powder
Solubility	Practically insoluble in water, Sparingly soluble in methylene chloride, slightly soluble in ethanol (95%) and in methanol.
Identification A) Melting Point B) By UV C) By IR D) By TLC E) Chemical test	(A) Not less Than 169°C and not more than174°C (B) Examined between 230nm and 350nm the solution shows an absorption maximum at 300 nm and a less intense maximum at 275nm. the Specific absorbance at the maxima are 61 to 65 and 27 to 32 respectively, (C) The infra-red absorption spectrum of test substances should be Concordant with the spectrum of Glibenclamide Standard. (D) The principal spot obtained with the test solution should be similar in Position and size to the prinicipal spot obtained in the chromatogram Obtained with the reference solution. (E) The solution is colourless and shows blue Fluorescence in ultraviolet light at 365 nm. Colour changes to deep yellow and, after abut 20 minutes develops a brownish tinge with Choral hydrate.
Heavy metal	NMT 20ppm
Sulphated Ash	NMT 0.1 %w/w
Related substances by HPLC	Impurity A NMT 0.5 % Impurity B NMT 0.5 % Any other Impurity NMT 0.2 % Two such Peak NMT 0.1 % Total of other impurities NMT 0.5 %
Loss on drying (at 105°C for three Hours)	NMT 1.0%w/w
Assay by Titrimetry on dried basis	NLT 99.0%w/w and NMT equivalent of 101.0%w/w
Residual Solvent by HSGC	Methanol NMT 3000 ppm Acetone NMT 5000 ppm Ethylene dichloride NMT 5 ppm