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API release

Concept Life Sciences' specialist release test laboratory offers a unique blend of high-end materials characterisation techniques (e.g. XRPD, PSD) combined with standard chromatographic (including LC, GC, TLC, IC) and elemental / compendial techniques (such as ICP, LoD, Karl Fischer) to meet niche requirements.

Concept offers a number of specialist API release services including raw material release of actives, excipients, solvents and packaging as well as niche FDF (Finished Dosage Form) release. We can apply our full suite of analytical equipment and expertise to API release, putting together both bespoke release test packages and standard compendial release test programmes.

Our facility is GMP certified and has been inspected by both the MHRA and FDA.

API release capabilities:

  • Incoming raw material release – actives, excipients, solvents, packaging
  • Processed API material release – actives, intermediates
  • Identification, Characters
  • Assay, related substances, stability indicating,
  • Powder properties, solid form, key performance indicators
  • FDF release
  • GMP certified
  • FDA inspected
  • MHRA inspected

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Concept Life Sciences provides an unrivalled breadth of analytical solutions, techniques and applications to the pharmaceutical, medical device and advanced wound management healthcare sectors. Concept is a specialist CRO focused on problem solving and delivering high quality analytical and laboratory support.

GMP stability

Concept Life Sciences offers GMP pharmaceutical stability studies and ICH storage services to support development, commercial stability studies and sample batch release. Concept’s stability team designs and delivers GMP stability programs for a comprehensive range of dosage forms, APIs and product types.

Pre-clinical formulation

Concept Life Sciences offers a comprehensive service for pre-formulation and formulation development plus GMP sample production for pre-clinical trial materials. We test and release formulations according to development specifications and produce samples under GMP conditions ready for transfer to study teams.