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Pharmaceutical Chemistry

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Teams are dedicated to method development , transfer, verification and validation, ensuring optimisation of methods used for release and stability testing. We offer stability storage and testing across all typical ICH guidelines

To support your commercial, stability product and clinical trial material release testing needs, Eurofins BioPharma Product Testing offers the capacity and breadth of capabilities to test your drug substance, drug product or in-process materials in a timely manner.


We test materials against specification for identity, potency, impurities, and physical properties under strict cGMP compliance, and we customise individual programs to streamline lab documentation and reporting for the most efficient and quality-focused data deliverable possible.

Our multi-shift laboratory operations are designed to provide extensive capacity for larger volume release programs, as well as flexibility for smaller programs in a manner that allows for aggressive cycle times. We have experience working with every type of modality and have the flexibility and extensive instrument capacity within our team to meet the ever-changing demands of production schedules and timelines.

  • Drug product analysis (tablets, capsules, patches, powders, liquids, etc)
  • Development, transfer, validation, verification
  • Release testing, marketed product, clinical studies, stability testing, R&D, comparators
  • Appearance/identification
  • Assay/potency/content uniformity
  • Product specific testing
  • 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
  • Heavy metals by ICP-MS

No bio/pharmaceutical product can be manufactured without first establishing the identity, purity and quality of its starting materials to ensure the product is suitable for its intended use. When this critical step in the bio/ pharmaceutical manufacturing process is performed successfully, costly production problems and delays can be avoided.

Eurofins BioPharma Product Testing has the wide range of chemistry expertise and state-of-the-art instruments required to perform all types of raw materials testing, including qualification of compendial methods, as well as development and validation of new methods.

Whether you are looking for assistance in the release of your raw materials for production purposes or in the qualification of your vendors, we can help keep your project on track. All of our testing is performed in accordance with EP, USP/NF, BP and JP methodologies and monographs, in addition to any client-supplied or vendor-defined methods.

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

  • Complete compendia analysis (USP, Ph. Eur., JP, CP, BP, ACS)
  • Raw materials, excipients, and API testing
  • Method development, feasibility, transfer, verification and validation
  • Method types include compendia and client specific, customised to  product specifications/requirements
  • Release testing supporting client QC and manufacturing. Streamlined to provide consistent high quality on-time delivery for established test methods.
  • Testing includes: 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>

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