Elixir Pharma - Glibenclamide

Glibenclamide

Common/INN Name: Glibenclamide or Glyburide

IUPAC Name : 5-chloro-N-(4-[N-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-methoxybenzamide

CAS No : 10238-21-8

Molecular Formula : C 23 H 28 ClN 3 O5 S

Molecular Mass : 494.004 gm/mol

Chemical Structure: :

Pharmacopeial Grade : IP/BP/EP/USP

Specifications :

A.P.I. Products List
S.No.	TEST	SPECIFICATION
1	Appearance	White or almost white, crystalline powder
2	Solubility	Practically insoluble in water, sparingly soluble in Methylene chloride, slightly soluble in alcohol and in methanol.
3
	Identification
	(A) Melting Point	169 °C to 174 °C.
	(B)  By UV	The solution shows an absorption maximum at 300 nm and a less intense maximum at 275 nm. The specific Absorbance at the maxima are 61 to 65 and 27 to 32,
	(C) By TLC	The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution.
	(D)By Colour Development	In resulting test solution should be colorless and shows blue fluorescence in ultraviolet light at 365 nm.
4	Related substances  (By HPLC)	-
4.1	Impurity A	NMT 0.5 per cent
4.2	Impurity B	NMT 0.5 per cent
4.3	Any Other Impurity:	NMT 0.2 per cent
4.4	Unknown Impurity-1	NMT 0.1 per cent
4.5	Unknown Impurity-2	NMT 0.1 per cent
4.6	Total Of Other Impurities:	NMT 0.5 per cent
5	Heavy metals	NMT 20 ppm
6	Loss on drying	NMT 1.0 % w/w
7	Sulphated ash	NMT 0.1 % w/w
8	Assay	Between 99.0 per cent to 101.0 per cent (dried substance)

Packing :25 Kg HDPE or Fiber Drums/ Custom Packing Available
Stability : Stable at ambient temperature
Usage: : Glibenclamide (INN), also known as glyburide (USAN), is an antidiabetic drug in a class of medications known as sulfonylureas, closely related to sulfa drugs. It was developed in 1966 in a cooperative study between Boehringer Mannheim (now part of Roche) and Hoechst (now part of Sanofi-Aventis). As of 2007, it is one of only two oral antidiabetics in the World Health Organization Model List of Essential Medicines (the other being metformin). As of 2003, in the United States, it was the most popular sulfonylurea.

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