GLP Characterization Studies
When a study is required to be conducted according to Good Laboratory Practices (GLPs) by global regulatory authorities, GLP characterization of the test and reference materials is required. Failure to do so will result in an Exception on the GLP Compliance Statement in the final study report.
GLP Characterization includes five essential points:
- Identity
- Strength
- Purity
- Composition
- Other Characteristics Which Appropriately Define the Test Substance
EAG’s Product Chemistry team – combined with the outstanding reputation of EAG’s Quality Assurance Unit – have extensive expertise and experience in the characterization of test articles to meet compliance with EPA (FIFRA and TSCA) and FDA Good Laboratory Practice regulations.
EAG can characterize the purity and identification of your test article by a variety of techniques, including:
- HPLC (UV, DAD, FLD, RI, ELSD)
- GC (FID, NPD, ECD, FPD)
- ICP-MS/ICP-OES
- Ion Chromatography
- Titration
- LC-MS
- GC-MS
- FTIR
- UV-VIS
- NMR (Outsourced to a GLP laboratory)
- GLP Characterization of Radiolabeled Materials
Count on EAG for technical excellence, sound regulatory advice, GLP-compliant study execution and expert interpretation of data to inform your commercial decisions!
Would you like to learn more about GLP Characterization Studies?
Contact us today for your GLP characterization study needs. Please complete the form below to have an EAG expert contact you.