Promethazine Impurity 26 CAS 15521-18-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.15521-18-3
Molecular FormulaC5H13NO
Molecular Weight103.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Promethazine Impurity 26 CAS 15521-18-3 chemical structure

Description

As a process- or degradation-related impurity, Promethazine Impurity 26 (CAS 15521-18-3, C5H13NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Promethazine Impurity 26 (C5H13NO) contains an amide group, a hydroxyl group, an ether linkage. Its physicochemical properties are representative of its class; 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), Promethazine Impurity 26 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 FormulaC5H13NO
Molecular Weight103.16 g/mol
Purity97%+
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)0.0
CAS Registry Year (est.)1961
Nitrogen Atoms1

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