Compliant systems and processes have been developed to ensure the efficient generation of quality data, right first time, on time.

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Experience + Expertise + Knowledge = Excellence

Helping you find the answers, Right First Time.

Using our extensive practical knowledge in the analysis of a wide range of dosage forms we are able to provide a comprehensive range of analytical services to support clients’ product development programmes, from simple ID testing and analytical method transfers, through method development and validation, to EU product release and ICH stability testing. All services are offered on a standalone basis or in conjunction with our clinical, commercial and QP services.

Our purpose-built laboratory features best-in-class qualified equipment and is fully-compliant with cGMP and ICH requirements, ensuring data reliability and regulatory compliance.

The analytical facility includes a containment laboratory featuring a HEPA filtered air-handling system for the analysis of cytotoxic, teratogenic and uncharacterised products and a darkroom for the analysis of light-sensitive products.

Product testing

  • Import Identity
  • Post-pack Identity
  • EU release testing
  • Pharmacopoeial testing (USP, Ph. Eur, BP, JP) of API’s, excipients and finished products

Method development and validation

  • Method development and optimisation of existing methodologies
  • Method validation appropriate to the drug product life cycle stage to ICH guidelines
  • Stability indicating assays
  • Generation of protocols and detailed validation reports

Stability storage and testing

  • Testing and storage to ICH guidelines (2oC - 8oC, 25oC/60%RH, 30oC/65%RH, 40oC /75%RH)
  • Customised storage conditions can be accommodated upon request
  • Protocol design
  • Disaster recovery plan to ensure your stability program is uninterrupted.

The techniques we offer include:

  • Gradient HPLC’s equipped with photo-diode array, variable UV, refractive index
  • GPC
  • GC/FID with head space
  • UV and FTIR spectroscopy
  • Dissolution testing
  • Volumetric and coulometric moisture determination
  • Particle size distribution
  • Physical testing apparatus for tablet/capsule formulations

Add our highly-qualified professional personnel and you have the pro-active approach to project management and problem-solving that Brecon is noted for.

Download our Analytical Services Brochure (PDF)