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Home Active Pharmaceutical Ingredients 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

Test Specification
Description White or almost white crystalline powder

(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 3

Solubility Practically insoluble in water, Sparingly soluble in methylene chloride, slightly soluble in ethanol (95%) and in methanol.
Heavy Metals NMT 20ppm
Loss On Drying NMT 1.0%w/w
Assay on dried basis by HPLC NLT 99.0%w/w and NMT equivalent of 101.0%w/w
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 %

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