Raw Materials and Excipients Testing Services

Our comprehensive testing covers APIs, excipients, raw materials, packaging components, cell banks, vectors, and bulk harvest materials. Each analysis validates material quality to support your manufacturing processes while maintaining regulatory compliance throughout development and production phases. From early-stage development to commercial manufacturing, we provide specification and characterization testing for vendor qualification and material release.

Access full monograph analysis, wet chemistry testing, spectrophotometric analysis (FT-IR, UV-VIS), residual solvents testing per USP <467>, elemental analysis, trace metals detection per USP <232> and <233>, ethylene oxide testing, and microbial analysis. Our testing capabilities include:

• Full Monograph Analysis (USP, Ph. Eur., JP, BP, ACS, FCC)
• Wet Chemistry Testing
• Assays and Chemical Tests
• Spectrophotometric Analysis (FT-IR, UV-VIS)
• Residual Solvents as per USP <467>
• Elemental Analysis
• Trace Metals as per USP <232> and <233>
• Ethylene Oxide and 1,4-Dioxane Testing
• Diethylene glycol (DEG) and Ethylene glycol (EG) Testing
• Microbiology and Sterility Testing
• Method Verification of Compendial Methods
• Tailored Methods including Method Development and Validation

Benefit from our technical expertise in method verification of compendial methods, existing method transfer and optimization, and custom method development services. Our solutions adapt to your specific requirements while maintaining strict compliance throughout your development pipeline. We support verification of existing test methods, method transfers, optimizations, and development of alternative release methods, all validated to meet your requirements.

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. This network of cGMP compliant and ISO/IEC 17025 accredited laboratories ensures consistent quality and regulatory compliance across regions, giving you access to local expertise with global standards. Find out where your nearest Life Sciences hub is on our Locations Page.

Optimize your testing processes with specialized knowledge in method verification, transfer, and development. Our team helps streamline your analytical procedures while maintaining regulatory compliance. We focus on supporting your specific testing needs across the entire development lifecycle, from early research through commercial production.