API standards

Pharmaceutical-Grade API Reference Standards for Identity Testing, Potency Assays, and Regulatory Submissions

Clinivex supplies API reference standards with defined purity, fully assigned structure, and documented traceability, providing the primary reference materials essential for HPLC assay calibration, dissolution testing, content uniformity determination, and residual impurity quantification in both drug substance and drug product quality control environments. Our catalog includes compendial standards aligned with USP, EP, BP, and JP pharmacopeial monographs alongside non-compendial working standards and house reference standards developed for proprietary APIs not yet covered by official pharmacopeias. Each material is characterized using a battery of orthogonal techniques, including quantitative NMR (qNMR), differential scanning calorimetry (DSC), Karl Fischer titration, and mass spectrometry to establish absolute purity with metrological rigor appropriate for primary standard designation. For corresponding impurity qualification standards required alongside your API testing program, our drug impurity reference standards catalog provides the process-related, degradation product, and genotoxic impurity standards needed for ICH Q3A/Q3B compliant submissions.

Every API reference standard from Clinivex is accompanied by a comprehensive Certificate of Analysis (CoA) detailing assigned purity, measurement uncertainty, characterization methodology, and storage and handling specifications fully compliant with USP <11> reference standard requirements, ICH Q6A specifications, and FDA cGMP expectations. Sourced from ISO 17025-accredited and GMP-certified manufacturers with established pharmacopeial supplier qualifications, our API reference materials provide the metrological foundation and audit-ready documentation your quality management system demands. For API compounds not yet characterized by official pharmacopeias, explore our active pharmaceutical ingredient standards catalog offering proprietary working standards for novel chemical entities and fixed-dose combination products. Reach out to our technical team to discuss catalog availability, primary versus secondary standard options, or custom reference standard development.