Quality Control Raw Material Testing
Before manufacturing begins, all raw materials must be tested for purity, identity and quality. Depending on the type of product (tablets and capsules vs. biotech products), as few as 15-20 to as many as 60 raw materials might be needed for product development. 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.
Pacific BioLabs offers comprehensive testing services per pharmacopiea (USP, EP, BP and JP) and to your specifications. Our analytical chemistry and microbiology teams can help you with the necessary testing for raw materials, APIs, finished products, packaging materials and medical devices.
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
- Assays and chemical tests
- Identification of active ingredients and impurities
- Physico-chemical determinations
- Particle size
- Osmolality and osmolarity
- Loss on drying
- Limit tests
- Heavy metals
- Residual solvents
- Volatile organic compounds (VOC)
- Organic volatile impurities (OVI)
- Water testing for pharmaceutical purposes and controlled process environments (e.g. TOC, conductivity)
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