Prucalopride Impurity 33 CAS 748788-40-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.748788-40-1
Molecular FormulaC22H20Br2Cl2N2O8
Molecular Weight671.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Prucalopride Impurity 33 CAS 748788-40-1 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Prucalopride Impurity 33.

As a process- or degradation-related impurity, Prucalopride Impurity 33 (CAS 748788-40-1, C22H20Br2Cl2N2O8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Prucalopride Impurity 33 (C22H20Br2Cl2N2O8) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine/bromine 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.

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 FormulaC22H20Br2Cl2N2O8
Molecular Weight671.12 g/mol
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.)1986
Halogen ContentCl/Br-containing
Nitrogen Atoms2

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