Nicergoline EP Impurity B CAS 35264-46-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.35264-46-1
Molecular FormulaC23H24BrN3O3
Molecular Weight470.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nicergoline EP Impurity B CAS 35264-46-1 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 Nicergoline EP Impurity B.

As a process- or degradation-related impurity, Nicergoline EP Impurity B (CAS 35264-46-1, C23H24BrN3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Nicergoline EP Impurity B (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.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Nicergoline EP Impurity B 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)
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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1967
Halogen ContentBr-containing
Nitrogen Atoms3

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