Pirfenidone Impurity 36 CAS 53427-80-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.53427-80-8
Molecular FormulaC12H10ClNO
Molecular Weight219.67 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pirfenidone Impurity 36 CAS 53427-80-8 chemical structure

Description

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.

Pirfenidone Impurity 36 (CAS 53427-80-8) is a certified pharmaceutical impurity reference standard with the molecular formula C12H10ClNO and a molecular weight of 219.67 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Pirfenidone Impurity 36 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 219.67 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).

As a certified reference material (CRM), Pirfenidone Impurity 36 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 FormulaC12H10ClNO
Molecular Weight219.67 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972
Halogen ContentCl-containing
Nitrogen Atoms1

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