Metformin EP Impurity C CAS 1985-46-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1985-46-2
Molecular FormulaC5H10N6
Molecular Weight154.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Metformin EP Impurity C CAS 1985-46-2 chemical structure

Description

Metformin EP Impurity C (CAS 1985-46-2) is a certified pharmaceutical impurity reference standard with the molecular formula C5H10N6 and a molecular weight of 154.17 g/mol.

Owing to a nitrile group, Metformin EP Impurity C is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 154.17 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Metformin EP Impurity C 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 FormulaC5H10N6
Molecular Weight154.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
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)4.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1957
Nitrogen Atoms6

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