Our Approach to Qualification and Traceability

Techniques We Use for Identity, Purity, and Potency

Reference standards are foundational to accurate and reliable analytical testing. Whether used for method development, validation, or lot release, properly qualified reference materials are critical to ensuring data integrity in cGMP environments. At Triclinic Labs, we offer full-service reference standard qualification using robust analytical techniques and documentation aligned with FDA, ICH, and USP guidelines. We verify identity, assess purity, determine potency, and ensure stability so your reference materials are ready for regulatory use. Our qualification programs support internal working standards, compendial standards, and third-party commercial materials. You'll receive a comprehensive data package—including COA, test protocols, chromatograms, and purity assessments—prepared by our cGMP-compliant quality system. Techniques we use include: High-performance liquid chromatography (HPLC) Gas chromatography (GC) Mass spectrometry (MS) Karl Fischer moisture analysis Melting point determination Elemental analysis (ICP-MS, CHN) We also support impurity standards, degradation markers, and material traceability programs. Let our experienced scientists ensure your standards meet regulatory expectations and analytical needs.