APIs / Active Pharmaceutical Ingredients

Traceable Active Pharmaceutical Ingredient Reference Standards for Method Validation, QC Testing, and Regulatory Compliance

Clinivex supplies active pharmaceutical ingredient standards characterized to primary or secondary reference standard specifications, providing pharmaceutical laboratories with the metrologically sound anchor materials needed for HPLC and UPLC assay calibration, dissolution method development, content uniformity testing, and quantitative impurity threshold evaluation against established ICH Q3A and Q3B limits. Our catalog encompasses both pharmacopeial-aligned active pharmaceutical ingredient reference standards traceable to USP, EP, BP, and JP official standards and proprietary working standards developed for novel chemical entities (NCEs), fixed-dose combination products, and biosimilar reference drug substances not yet assigned official monograph status. For a curated selection of compendial-grade drug substance characterization materials, our API reference standards catalog provides primary standard options with qNMR-based absolute purity assignments and DSC solid-state profiling.

Every active pharmaceutical ingredient reference standard ships with a fully traceable Certificate of Analysis (CoA) capturing assigned purity, measurement uncertainty, traceability chain, and stability-based retest dating aligned with USP <11>, ICH Q6A, and cGMP requirements. Sourced from ISO 17025-accredited and GMP-compliant manufacturers, our standards integrate seamlessly into your supplier qualification program and analytical method lifecycle documentation. For compound-specific impurity qualification alongside your API characterization program, our pharmaceutical impurity standards provide the process-related and degradation product references essential for ICH-compliant regulatory filings. Contact our scientific team to explore catalog options or initiate a custom reference standard development project.