Revefenacin Impurity 16 HCl CAS 886508-20-9(Free Base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.886508-20-9(Free Base)
Molecular FormulaC12H21N3O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Revefenacin Impurity 16 HCl CAS 886508-20-9(Free Base) chemical structure

Description

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.

As a process- or degradation-related impurity, Revefenacin Impurity 16 HCl (CAS 886508-20-9(Free Base), C12H21N3O2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Revefenacin Impurity 16 HCl (C12H21N3O2HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

Physical & Chemical Properties

Molecular FormulaC12H21N3O2 HCl
Molecular Weight275.78 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
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)3.0
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms3

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