Pirfenidone Impurity 42 CAS 3510-66-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.3510-66-5
Molecular FormulaC6H6BrN
Molecular Weight172.02 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pirfenidone Impurity 42 CAS 3510-66-5 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 Pirfenidone Impurity 42.

As a process- or degradation-related impurity, Pirfenidone Impurity 42 (CAS 3510-66-5, C6H6BrN) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrile group, bromine substitution, an aromatic ring system, Pirfenidone Impurity 42 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 172.02 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

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

Molecular FormulaC6H6BrN
Molecular Weight172.02 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Halogen ContentBr-containing
Nitrogen Atoms1

Related Pirfenidone Standards

Recommended Standards

Why CATO?