API Name : API Labeled Standards

API Labeled Standards

Venkatasai is a leading provider of pharmaceutical reference standards, specializing in the supply of high-purity API Labeled Standards reference materials. Our portfolio includes both pharmacopeial and non-pharmacopeial impurities, metabolites, stable isotope-labeled compounds, and nitrosamine derivatives (N-NO products). These reference standards play a crucial role in pharmaceutical R&D, aiding in formulation development, ANDA/DMF submissions, quality control, method validation, stability studies, and impurity profiling—including the identification and assessment of potentially genotoxic impurities.

Each API Labeled Standards-related product is rigorously characterized and delivered with a detailed Certificate of Analysis (COA) and comprehensive analytical data to ensure regulatory compliance. Upon request, we also offer EP/USP traceable standards. To maintain the highest quality standards, all materials are subject to periodic re-testing and continuous quality monitoring.