Niraparib Impurity 68 CAS CATO-C4X-232968

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-232968
Molecular FormulaC19H20N4O
Molecular Weight320.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Niraparib Impurity 68 CAS CATO-C4X-232968 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 Niraparib Impurity 68.

CATO supplies Niraparib Impurity 68 (CAS CATO-C4X-232968), a pharmacopoeial impurity reference standard (molecular formula C19H20N4O, MW 320.39 g/mol) used for the identification and quantification of trace impurities in APIs.

Niraparib Impurity 68 (C19H20N4O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. 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.

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 FormulaC19H20N4O
Molecular Weight320.39 g/mol
AppearancePale yellow to yellow crystalline powder
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

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