Promethazine lmpurity 32 CAS CATO-C4X-141832

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-141832
Molecular FormulaC4H10ClN
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Promethazine lmpurity 32 CAS CATO-C4X-141832 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 lmpurity 32.

CATO supplies Promethazine lmpurity 32 (CAS CATO-C4X-141832), a pharmacopoeial impurity reference standard (molecular formula C4H10ClNHCl, MW 144.04 g/mol) used for the identification and quantification of trace impurities in APIs.

Promethazine lmpurity 32 (C4H10ClNHCl) contains chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 lmpurity 32 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 FormulaC4H10ClN HCl
Molecular Weight144.04 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-1.0
Halogen ContentCl-containing
Nitrogen Atoms1

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