Raw Material, API & Excipient Testing
Ensuring material quality for optimal manufacturing, stability, and regulatory compliance.
Raw Material, API and Excipient Testing
Material quality can affect manufacturing, finished product performance, stability, and regulatory compliance. Globyz Clinical Solutions provides chemical and instrumental testing for accepted raw materials, active pharmaceutical ingredients, and excipients against approved specifications and suitable methods.
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Material Integrity
Approved specifications & methods
Potential Testing Services
Globyz Clinical Solutions provides comprehensive analytical testing for raw materials, active pharmaceutical ingredients, excipients, finished pharmaceutical products, natural health products and cosmetics.
These services support product-quality assessment, compliance with established specifications, manufacturing and release decisions, investigations and regulatory documentation.
Testing Capabilities Include:
- Identity and assay testing
- Evaluation of related substances and specified/elemental impurities
- Determination of water content, loss on drying and pH
- Assessment of relevant physicochemical characteristics
- Compendial and product-specific quality testing
What We Need
Please provide the following information to facilitate swift evaluation and initiation of your testing project.
Supplier Data & Reduced Testing
Reduced testing is not automatic.
Any reduced testing approach should be based on approved specifications, supplier qualification, satisfactory historical data, documented risk assessment, periodic full confirmatory testing, defined return to full testing criteria, and written quality approval.
Clear Reporting
Results are compared with the approved acceptance criteria and issued in the agreed controlled report.
Material disposition remains the client's responsibility unless a separate authorized quality role is explicitly contracted.
Accelerate Your Analytical Testing
Get in touch with our experts to discuss your pharmaceutical analytical testing needs and ensure absolute compliance and quality.