Risperidone EP Impurity A and B(Mixture of E and Z Isomers) CAS 158697-66-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.158697-66-6
Molecular FormulaC23H28F2N4O2
Molecular Weight430.49 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Risperidone EP Impurity A and B(Mixture of E and Z Isomers) CAS 158697-66-6 chemical structure

Description

As a process- or degradation-related impurity, Risperidone EP Impurity A and B(Mixture of E and Z Isomers) (CAS 158697-66-6, C23H28F2N4O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Risperidone EP Impurity A and B(Mixture of E and Z Isomers) (C23H28F2N4O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 430.49 g/mol, it falls into the moderately-high-molecular-weight range. 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.

CATO manufactures Risperidone EP Impurity A and B(Mixture of E and Z Isomers) 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 FormulaC23H28F2N4O2
Molecular Weight430.49 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2002
Halogen ContentF-containing
Nitrogen Atoms4

Related Risperidone Standards

Recommended Standards

Why CATO?