Ranitidine

Ranitidine Impurities

Ranitidine impurities include process-related compounds, synthetic intermediates, degradation products, and nitrosamine contaminants that may arise during synthesis, formulation, or storage. As an H2-receptor antagonist formerly used to treat peptic ulcers and gastroesophageal reflux disease, impurity profiling is essential for ensuring product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Ranitidine EP Impurities

Pharmacopeial and non-pharmacopeial Ranitidine 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 are supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Ranitidine Related Compounds

Structurally related compounds and synthetic analogs associated with Ranitidine 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.

Ranitidine Impurity Reference Standards

Ranitidine 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.