Raw material testing verifies the identity, quality, purity, consistency and suitability of materials used throughout pharmaceutical manufacturing, including APIs, excipients, starting materials, intermediates, solvents, process chemicals and water.
Raw material quality is the foundation of safe, effective and compliant pharmaceutical products. Variability in active pharmaceutical ingredients (APIs), excipients and processing materials can affect product quality, manufacturing performance and regulatory compliance.
We perform GMP quality control, characterization, compendial and compliance testing on pharmaceutical raw materials, including APIs, excipients, starting materials, intermediates, solvents, process chemicals and water used in pharmaceutical manufacturing, supporting materials used in both clinical and commercial manufacturing.
Ensure the quality of your pharmaceutical raw materials
- Confirm raw material identity
Verify that incoming materials conform to established specifications through compendial and validated analytical methods.
- Assure purity and safety
Detect contaminants, degradants and manufacturing residues through impurity and trace-level contaminant analysis.
- Support supplier qualification
Generate data to support supplier qualification programs and incoming material release decisions.
- Strengthen manufacturing consistencyRely on consistent raw material testing to support manufacturing process consistency and change control assessments.
- Support regulatory readinessAccess testing data that supports regulatory submissions and inspections.
Discover our raw material testing capabilities
- Identity testingWe verify that incoming materials conform to established specifications through compendial and validated analytical methods, including FTIR, UV-Vis spectroscopy, HPLC and GC identification.
- Purity and impurity testingWe assess material purity and detect contaminants, degradants and manufacturing residues through related substances testing, residual solvents, elemental impurities and trace-level contaminant analysis.
- Physicochemical characterizationWe evaluate critical material attributes, including assay and content determination, water content, pH, density, viscosity, particle size distribution and solubility.
- Microbiological testingWhere applicable, we perform bioburden, microbial limits, bacterial endotoxins and water quality testing.
- Compendial compliance testingWe test against recognized pharmacopoeial monographs, including USP-NF, European Pharmacopoeia (Ph. Eur.), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP) and client-specific specifications.
Why SGS?
As the world's leading testing, inspection and certification company, we combine GMP-compliant laboratories with deep pharmaceutical raw material testing expertise to support your supply chain quality program. We help pharmaceutical and biotechnology companies mitigate supply chain risks, maintain consistent manufacturing processes and confirm that materials meet global regulatory and quality expectations before use in clinical or commercial manufacturing.
FAQs
We provide identity testing, purity and impurity testing, physicochemical characterization, microbiological testing and compendial compliance testing for pharmaceutical raw materials.
We test active pharmaceutical ingredients (APIs), excipients, starting materials, chemical intermediates, solvents, reagents, process chemicals and water used in pharmaceutical manufacturing.
Raw material testing supports supplier qualification programs, incoming material release, change control and comparability assessments, investigations and deviation management, manufacturing process consistency, and regulatory submissions and inspections.
16th Floor, Block A, No.73 Fucheng Road, Century Yuhui Mansion,
Beijing, Haidian District, China