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Home » Products » Active Pharmaceutical Ingredients » Glimepiride USP-EP-BP-IP

Glimepiride USP-EP-BP-IP

Glimepiride USP-EP-BP-IP
Glimepiride USP-EP-BP-IP
Product Code : 003
Product Description

Our company is of the prominent manufacturers and suppliers of Glimepiride USP-EP-BP-IP in India. We offer quality range of Glimepiride Usp-Ep-Bp-Ip to our clients who are from different verticals and we meet the national and international quality standards. We process this product with high quality raw materials. Our company possesses a team of professionals, who check the quality from the start by procuring of raw materials till the reach of the product to clients destination. Further, we ensure to reach the product within the stipulated time frame.

  • Formula of Glimepiride: C24H34N4O5S
  • CAS of Glimepiride : 93479-97-1
  • Molecular weight : 490.6
  • CAS Number : 93479-97-1
  • Uses of Glimepiride: Anti Diabetic, Inhibition of ATP-dependent potassium channels (sulfonylurea); treatment of diabetes  mellitus.  
  • Specification of Glimepiride: As per USP/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.
  • Synonyms of Glimepiride: 3-ethyl-4-methyl-N-(4-[N-((1r,4r)-4-methylcyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide

Impurity Profile of Glimepiride

By Related Substance by HPLC

  • Related Compound B: Not More than 0.4%
  • Related Compound C: Not More than 0.1%
  • Related Compound D: Not More than 0.1%
  • Individual Impurity: Not More than 0.1%
  • Total Impurity: Not More than 0.5%

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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