Promethazine Impurity 23 CAS 64505-48-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.64505-48-2
Molecular FormulaC4H9NO2
Molecular Weight103.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Promethazine Impurity 23 CAS 64505-48-2 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 Promethazine Impurity 23.

As a process- or degradation-related impurity, Promethazine Impurity 23 (CAS 64505-48-2, C4H9NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Promethazine Impurity 23 (C4H9NO2) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), Promethazine Impurity 23 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 FormulaC4H9NO2
Molecular Weight103.12 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1975
Nitrogen Atoms1

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