Pharmaceutical Chemistry

At Eurofins BioPharma Product Testing UK, we specialise in a broad spectrum of analytical instrumentation. Our dedicated teams excel in method development, transfer, verification, and validation, ensuring optimal methods for release and stability testing. We adhere to all standard ICH guidelines for stability storage and testing.

We support your commercial, stability product, and clinical trial material release testing needs with extensive capabilities to test drug substances, drug products, and in-process materials promptly.

• Identity, Potency, and Impurities Testing: We test materials against specifications for identity, potency, impurities, and physical properties under strict cGMP compliance. Our customised programmes streamline lab documentation and reporting for efficient, quality-focused data delivery.
• Flexible Laboratory Operations: Our multi-shift operations provide extensive capacity for large volume release programmes and flexibility for smaller programmes, accommodating aggressive cycle times. We handle all types of modalities and adapt to changing production.

• Drug Product Analysis: Tablets, capsules, patches, powders, liquids, etc.
• Method Development and Validation: Development, transfer, validation, verification.
• Release Testing: Marketed products, clinical studies, stability testing, R&D, and comparators.
• Specific Testing: Appearance/identification, assay/potency/content uniformity, impurity analysis (process impurities, degradants, related substances), dissolution (USP 1, 2, 5) and disintegration testing, water content (volumetric and coulometric), cleaning verification method development, validation, and testing, elemental impurities testing by ICP-MS.

No bio/pharmaceutical product can be manufactured without first establishing the identity, purity, and quality of its starting materials. Successful execution of this critical step prevents costly production problems and delays.

• Wide Range of Chemistry Expertise: We perform all types of raw materials testing, including qualification of compendial methods and development and validation of new methods.
• Vendor Qualification: Assistance in the release of raw materials for production purposes or vendor qualification to keep your project on track. Testing is performed in accordance with Ph.Eur., USP/NF, BP, and JP methodologies and monographs, as well as client-supplied or vendor-defined methods.

Our extensive testing experience, coupled with expertise in scientific problem-solving and compendial consultation, allows us to meet your testing challenges successfully.

• Complete Compendia Analysis: USP, Ph. Eur., JP, CP, BP, ACS.
• Raw Materials, Excipients, and API Testing: Method development, feasibility, transfer, verification, and validation.
• Customised Method Types: Compendia and client-specific, tailored to product specifications/requirements.
• Release Testing: Supporting client QC and manufacturing with consistent high-quality, on-time delivery for established test methods.
• Testing Capabilities: FAAS, HPLC/UPLC, GC, GC/MS, TLC, autotitration, LOD, conductivity, osmolality, UV, melting point, polarimetry, viscosity, FTIR, ROI, KF, residual solvents EP 2.4.24 and USP <467>.

Let us help you ensure the quality and compliance of your bio/pharmaceutical products with our expert testing services.