Promethazine Impurity 72 CAS 409314-72-3

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.409314-72-3
Molecular FormulaC4H10ClN
Molecular Weight107.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Promethazine Impurity 72 CAS 409314-72-3 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 72.

As a process- or degradation-related impurity, Promethazine Impurity 72 (CAS 409314-72-3, C4H10ClN) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Promethazine Impurity 72 (C4H10ClN) 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 Impurity 72 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
Molecular Weight107.58 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)0.0
CAS Registry Year (est.)2025
Halogen ContentCl-containing
Nitrogen Atoms1

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