Metformin EP Impurity A CAS 461-58-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.461-58-5
Molecular FormulaC2H4N4
Molecular Weight84.08 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Metformin EP Impurity A CAS 461-58-5 chemical structure

Description

As a process- or degradation-related impurity, Metformin EP Impurity A (CAS 461-58-5, C2H4N4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Metformin EP Impurity A (C2H4N4) contains a nitrile group. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Metformin EP Impurity A under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC2H4N4
Molecular Weight84.08 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1957
Nitrogen Atoms4

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