Gemcitabine

Gemcitabine Impurities

Gemcitabine impurities include process-related substances, degradation products, and structurally related analogs that may arise during synthesis, formulation, or storage. As a nucleoside analog used in chemotherapy, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity materials are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Gemcitabine EP Impurities

We offer pharmacopeial and non-pharmacopeial Gemcitabine impurities that conform to European Pharmacopoeia (EP) specifications. These standards support method development, impurity profiling, and stability studies. EP traceable materials are available upon request and are supplied with validated analytical data including HPLC purity, NMR, and MS characterization.

Gemcitabine Related Compounds

Our catalog includes structurally related compounds and synthetic intermediates associated with Gemcitabine. These materials are used in forced degradation studies, impurity identification, and genotoxicity assessments. All entries are supported by comprehensive analytical documentation and meet international regulatory expectations.

Gemcitabine Impurity Reference Standards

Gemcitabine impurity reference standards are supplied with validated analytical data including NMR, MS, and HPLC purity. These materials are used in pharmaceutical R&D, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request. All products are re-tested at regular intervals to ensure consistency and reliability.