Nicergoline EP Impurity E CAS 57935-66-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.57935-66-7
Molecular FormulaC23H24BrN3O3
Molecular Weight470.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nicergoline EP Impurity E CAS 57935-66-7 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 Nicergoline EP Impurity E.

CATO supplies Nicergoline EP Impurity E (CAS 57935-66-7), a pharmacopoeial impurity reference standard (molecular formula C23H24BrN3O3, MW 470.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Nicergoline EP Impurity E (C23H24BrN3O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Nicergoline EP Impurity E meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC23H24BrN3O3
Molecular Weight470.36 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Halogen ContentBr-containing
Nitrogen Atoms3

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