Glibenclamide

Glibenclamide

Glibenclamide

We are leading manufacturer and exporter of Glibenclamide and our product is made up of good quality.

Product NameGlibenclamide BP/EP/USP
Chemical Name5-chloro-N-(4-[N-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-methoxybenzamide
CAS Number10238-21-8
Chemical FormulaC23H28ClN3O5S
Molecular Mass494.01 g/mol
Therapeutic CategoryAntidiabetic

Instructions of Glibenclamide :

TestSpecification
DescriptionWhite or almost white crystalline powder
SolubilityPractically 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 metalNMT 20ppm
Sulphated AshNMT 0.1 %w/w
Related substances by HPLCImpurity 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 basisNLT 99.0%w/w and NMT equivalent of 101.0%w/w
Residual Solvent by HSGCMethanol NMT 3000 ppm
Acetone NMT 5000 ppm
Ethylene dichloride NMT 5 ppm
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Purpose of Requirement:

Reselling End Use Raw Material

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    Sanjay Totre

    (Managing Director)

    Yashica Pharmaceuticals Private Limited

    Syndicate, Thane, Maharashtra, India

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