Dolutegravir Impurity 28 CAS 1646862-09-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1646862-09-0
Molecular FormulaC18H16F2N2O6
Molecular Weight394.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dolutegravir Impurity 28 CAS 1646862-09-0 chemical structure

Description

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.

Dolutegravir Impurity 28 (CAS 1646862-09-0) is a certified pharmaceutical impurity reference standard with the molecular formula C18H16F2N2O6 and a molecular weight of 394.33 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Dolutegravir Impurity 28 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 394.33 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

CATO manufactures Dolutegravir Impurity 28 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 FormulaC18H16F2N2O6
Molecular Weight394.33 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Halogen ContentF-containing
Nitrogen Atoms2

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