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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