Pharmaceutical excipients

Excipients affect how a tablet compresses, how fast it dissolves and how stable it stays, so a grade change can change the product. Suppliers offer several grades of the same excipient that differ in particle size, density, viscosity or substitution level, and formulators select one grade and keep it.

Ask for compliance with the USP-NF, Ph. Eur., JP or IP monograph, and look for suppliers that follow excipient GMP guidance such as the IPEC and PQG principles. Useful documents include a certificate of analysis, statements on residual solvents, elemental impurities, TSE and BSE status for animal-derived materials, allergens and nitrite levels, since nitrite in excipients can contribute to nitrosamine formation.