A Bioanalytical Reference Materials Testing Program
Authors
Elizabeth A. Groeber, Anders Ljungqvist, William Coontz, Derek Miller, Christopher J.L. Buggé, David B. Garcia
Purpose
To establish a reference materials testing program which will enable the bioanalytical laboratory to confirm identity, measure purity, assign expiration dates, issue certificates of analysis (COAs), and monitor the stability of neat materials. Such a program is valuable in order to ensure reference standard compounds are appropriately characterized before use in GLP compliant bioanalytical studies.
Methods
When purity information is lacking, or a reference standard compound is expired, a COA is generated. A variety of tests are performed such as chromatographic purity using reversed phase HPLC/UV and evaporative light scattering detection (ELSD), TLC, melting point, Karl Fischer, and LC/MS infusion. Additional tests such as elemental analysis, thermogravimetric analysis (TGA), and differential scanning calorimetry (DSC) may be appropriate. Use and storage of reference standards are closely controlled, and comprehensive lists of current and expired reference standards are maintained.
Results
The testing chemist compiles, reviews, and lists all test results on a COA. A senior scientist then reviews the data and assigns the purity for bioanalytical analysis, and the retest date. The data are then reviewed by QA, and the compound is made available for general use. The policies regarding the Reference Materials Testing Program, including COA testing and the assignment of expiration dates, have been incorporated into a Standard Operating Procedure.
Conclusions
The program enables the laboratory to perform purity testing and generate COAs, ensuring the reference standards are appropriately characterized and compliant for GLP studies.