Posaconazole Impurity 99 CAS CATO-C4X-120899

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-120899
Molecular FormulaC18H21F2N3O3
Molecular Weight365.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Posaconazole Impurity 99 CAS CATO-C4X-120899 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 Posaconazole Impurity 99.

As a process- or degradation-related impurity, Posaconazole Impurity 99 (CAS CATO-C4X-120899, C18H21F2N3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Posaconazole Impurity 99 (C18H21F2N3O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; 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).

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 FormulaC18H21F2N3O3
Molecular Weight365.37 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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