Dolutegravir O-Methyl Impurity CAS 1335210-35-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1335210-35-9
Molecular FormulaC21H21F2N3O5
Molecular Weight433.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dolutegravir O-Methyl Impurity CAS 1335210-35-9 chemical structure

Description

CATO supplies Dolutegravir O-Methyl Impurity (CAS 1335210-35-9), a pharmacopoeial impurity reference standard (molecular formula C21H21F2N3O5, MW 433.41 g/mol) used for the identification and quantification of trace impurities in APIs.

Dolutegravir O-Methyl Impurity (C21H21F2N3O5) 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 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 FormulaC21H21F2N3O5
Molecular Weight433.41 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentF-containing
Nitrogen Atoms3

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