Raw Materials and Excipients Testing Services

Minimize risk and expedite your development timeline with Element's comprehensive raw materials and excipient testing services. Our network of cGMP compliant and ISO/IEC 17025 accredited laboratories provides expert analysis from APIs to packaging materials. 

What is raw material and excipient testing?

Any raw material or active pharmaceutical ingredient (API) is required to meet the criteria outlined in 21 CFR 211.84 before it can be used in any manufacturing process or formulation. Raw material testing confirms both the identity and integrity of the material, ensuring that the right product has been received and that it meets the specifications that have been established for its intended use.

Element’s raw material testing supports the entire drug development lifecycle, from early-stage development to commercial manufacturing, with a comprehensive suite of services including specification and characterization testing for vendor qualification and the release of raw materials and excipients used in manufacturing. Our team of raw materials testing experts make use of a wide range of advanced analytical techniques and instrumentation. Additionally, monograph and compendial methods can be verified, existing test methods can be transferred, verified, and optimized, or alternative raw material release methods can be developed and validated.

Key Benefits of Raw Materials Testing with Element

• Guaranteed Quality and Compliance: Element ensures the purity, identity, strength and overall quality of your raw materials through comprehensive testing services. This adherence to strict regulations (like 21 CFR 211.84) safeguards the safety and efficacy of your finished product. 
• Expertise Across the Development Lifecycle: From early-stage development to commercial manufacturing, Element offers a wide range of testing solutions for raw materials, excipients, and APIs. Their team of experts utilizes advanced techniques to ensure your materials meet exact specifications and are suitable for their intended use.
• Efficiency and Flexibility: Element prioritizes speed and accuracy with expedited services to meet your manufacturing timelines. Their network of cGMP compliant and ISO accredited labs delivers high-quality control while offering flexible testing programs that can be tailored to your specific needs. 

Available Services

• 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

Supporting Your Raw Materials and Excipient Testing Journey

Inconsistent raw materials can jeopardize product safety and slow down development due to complex regulations and a lack of internal testing expertise. Element tackles these challenges by guaranteeing quality and compliance, offering phase-specific solutions throughout development and delivering fast, adaptable testing services. 

The Element Advantage

You can rely on Element to cater to all of your testing needs with our technical expertise. Learn more about how Element can deliver high-quality validated methods and/or speak with one of our experts by contacting us.