Bictegravir Impurity 9(2R,5R,13aR) CAS CATO-C4X-21819

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-21819
Molecular FormulaC21H18F3N3O5
Molecular Weight449.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bictegravir Impurity 9(2R,5R,13aR) CAS CATO-C4X-21819 chemical structure

Description

As a process- or degradation-related impurity, Bictegravir Impurity 9(2R,5R,13aR) (CAS CATO-C4X-21819, C21H18F3N3O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Bictegravir Impurity 9(2R,5R,13aR) (C21H18F3N3O5) contains a flavonoid 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.

CATO manufactures Bictegravir Impurity 9(2R,5R,13aR) under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC21H18F3N3O5
Molecular Weight449.38 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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