Promethazine

Promethazine Impurities

Promethazine impurities include synthetic intermediates, process-related compounds, and degradation products that may arise during manufacturing, formulation, or storage. As a first-generation phenothiazine antihistamine with antiemetic and sedative properties, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Promethazine EP Impurities

Pharmacopeial and non-pharmacopeial Promethazine impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and stability testing. EP traceable materials include sulfoxide derivatives, N-oxides, and phenothiazine analogs, supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Promethazine Related Compounds

Structurally related compounds and synthetic analogs associated with Promethazine are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Promethazine Impurity Reference Standards

Promethazine impurity reference standards are provided with validated analytical data including purity, NMR, and MS. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.