Glimepiride Impurity 20 CAS 607-97-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.607-97-6
Molecular FormulaC8H14O3
Molecular Weight158.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Glimepiride Impurity 20 CAS 607-97-6 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Glimepiride Impurity 20.

CATO supplies Glimepiride Impurity 20 (CAS 607-97-6), a pharmacopoeial impurity reference standard (molecular formula C8H14O3, MW 158.19 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Glimepiride Impurity 20 (C8H14O3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Glimepiride Impurity 20 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC8H14O3
Molecular Weight158.19 g/mol
Purity>95%
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1957

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