Pirfenidone EP Impurity B CAS 1003-68-5

Description

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

Pirfenidone EP Impurity B (CAS 1003-68-5) is a certified pharmaceutical impurity reference standard with the molecular formula C6H7NO and a molecular weight of 109.13 g/mol.

Pirfenidone EP Impurity B (C6H7NO) contains an amide group, a hydroxyl group, an ether linkage, an aromatic ring system. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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