Dabrafenib Impurity N1 CAS 1195765-47-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1195765-47-9
Molecular FormulaC22H18F3N5O2S2
Molecular Weight505.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabrafenib Impurity N1 CAS 1195765-47-9 chemical structure

Description

The occurrence of Dabrafenib Impurity N1 is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Dabrafenib Impurity N1 (CAS 1195765-47-9) is a certified pharmaceutical impurity reference standard with the molecular formula C22H18F3N5O2S2 and a molecular weight of 505.54 g/mol.

Dabrafenib Impurity N1 (C22H18F3N5O2S2) contains a steroid core, an amide group, a sulfone 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 FormulaC22H18F3N5O2S2
Molecular Weight505.54 g/mol
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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Halogen ContentF-containing
Nitrogen Atoms5
Sulfur Atoms2

Related Dabrafenib Standards

Recommended Standards

Why CATO?