USP Compendial Methods
Maxxam uses United States Pharmacopeia/ National Formulary (USP/NF) compendial testing methods for raw material and final product testing. Some of the compendial testing includes:
- Residual solvents testing by USP <467>
- Heavy metals by USP <231> and recently published USP <232>, <233> and <2232> “Elemental Impurities” instrumental methods (ICP-OES, ICP/MS, HPLC-ICP/MS) *
- Loss on Drying USP<731>
- Dissolution USP<711> (Apparatus Type II – paddles)
- Optical Rotation USP<781>
- Residue on Ignition USP<281>
- Individual Monographs by request
*We are fully aware of the impending changes to the USP <231> methodology, including the recently proposed general chapters on Elemental Impurities Limits and Methods published in the January-February issue of Pharmacopeial Forum PF 36(1). We continuously monitor new developments and, with over 22 years experience in applying ICP-MS in the pharmaceutical industry, are well positioned to support revised testing requirements. Please see our Elemental Impurities page for more information.
