Quality Control Raw Material Testing
Before manufacturing begins, all raw materials must be tested for purity, identity and quality. The extent of raw material testing is determined by the manufacturer. A conservative approach would be to perform complete analysis of each lot of raw materials received. USP provides monographs for the most commonly used raw materials in the pharmaceutical industry. Often these monographs detail several different analytical techniques. Karl Fischer moisture analysis, pH, viscosity and titrations are common but more complex techniques such as HPLC, GC-MS and ICP-MS are sometimes required.
Because of the many different techniques associated with raw material testing please visit our testing pages below, or instrumentation page, or contact us directly to discuss the testing you might require.
Testing Services for Raw Materials
- Physicochemical Properties
- Identity and Purity – Small Molecules
- Identity and Purity – Large Molecules
Read More About Raw Materials
- PBL’s Learning Center – Pharmaceutical CMC Expectations
- PBL’s Learning Center – CMC Activities for Biologics and Monoclonal Antibodies
- ICH 6QA – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- ICH 6QB – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products