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Raw Material, API & Excipient Testing

Ensuring material quality for optimal manufacturing, stability, and regulatory compliance.

Material Quality

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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Raw Material, API and Excipient Testing

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.

Current specification and method
Material name and grade
Supplier & manufacturer information
Certificate of Analysis (CoA)
Compendial reference
Sample quantity & storage requirements
Standards and target date
Intended regulatory market

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.

Output

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.

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Accelerate Your Analytical Testing

Get in touch with our experts to discuss your pharmaceutical analytical testing needs and ensure absolute compliance and quality.