Nelfinavir Oxazole Impurity (Impurity A) CAS 188936-07-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.188936-07-4
Molecular FormulaC26H39N3O4
Molecular Weight457.61 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nelfinavir Oxazole Impurity (Impurity A) CAS 188936-07-4 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 Nelfinavir Oxazole Impurity (Impurity A).

CATO supplies Nelfinavir Oxazole Impurity (Impurity A) (CAS 188936-07-4), a pharmacopoeial impurity reference standard (molecular formula C26H39N3O4, MW 457.61 g/mol) used for the identification and quantification of trace impurities in APIs.

Nelfinavir Oxazole Impurity (Impurity A) (C26H39N3O4) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC26H39N3O4
Molecular Weight457.61 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2010
Nitrogen Atoms3

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