Well-characterized reference substances make a crucial contribution to the accuracy of analyses in the pharmaceutical industry. Solvias provides a comprehensive service for reference substances of small molecules and biopharmaceuticals:
- Synthesis of reference substances, including development of the synthesis route where necessary
- Isolation, purification or enrichment of by-products needed as reference substances, for example by crystallization, extraction, or preparative chromatography (including prep-HPLC, Akta system).
- Characterization of reference substances, for example structural elucidation (MS, IR, NMR, etc.)
- Full certification, meeting GMP requirements
- Packaging, for example weighed quantities in vials, including certificate of analysis (can be performed either in-house or with external partners
- Storage and logistics
Details of the analytical certification program will be mutually agreed with the customer. Solvias can consult on best practices.