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Glimepiride

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Glimepiride

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Glimepiride

Specifications

Therapeutic Activity Anti Diabetic
Standards USP/ IP / BP/ EP
CAS. No. 93479-97-1

Glimepiride is an orally available medium-to-long acting sulfonylurea antidiabetic drug. It is sometimes classified as either the first third-generation sulfonylurea, or as second-generation.

 

Glimepiride is indicated to treat type 2 diabetes mellitus; its mode of action is to increase insulin production by the pancreas. It is not used for type 1 diabetes because in type 1 diabetes the pancreas is not able to produce insulin.

 

MOLECULAR STRUCTURE:

  • Molecular formula : C24H34N4O5S

  • Molecular weight : 490.6

  • CAS Number : 93479-97-1

  • Application :. Anti-Diabetic

  • Specification : As perUSP/ BP/ EP/ IP

  • Chemical Name [IUPAC Name]: 1-[[4-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)-ethyl]phenyl] sulphony l] -3-trans-(4-methylcyclohexyl)urea.


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Specifications (As per USP/BP/EP/IP)

Description

A white or almost white crystalline powder.

Solubility

Practically insoluble in water, soluble in dimethylformamide, slightly soluble in methylene chloride, very slightly soluble in methanol.

Identifications by IR

IR Spectrum matches with that of standard

Relative Impurities
Impurity B
Impurity D
Impurity C
Unspecified Impurities
Sum of Impurities other than B


Not More than 0.4%
Not More than 0.2%
Not More than 0.1%
Not More than 0.1%
Not More than 0.5%

Impurity A

Not More than 0.8%

Water (By K.F)

Not more than 0.5% w/w

Heavy Metals

Not more than 10 ppm

Sulphated Ash

Not more than 0.1% w/w.

Assay By HPLC

97% to 102% (anhydrous basis)

Particle Size

100% less than 10 micron


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