Batch Release Testing

Batch Release Testing

Within the European Union (EU), Good Manufacturing Practice (GMP) for Medicinal Products requires batch release against the approved product specification, for medicinal products holding a marketing authorisation. Our QC batch release testing laboratories utilise a wide range of analytical technologies to provide responsive release testing using pharmacopoeial or client specific methods, confirming that products meet their specification. Routinely handling a diverse range of sample matrices leaves ALS well positioned to meet the needs of our clients' ever expanding product portfolios and diverse product ranges.

Batch Release Testing Lab

Analytical Method Transfer (AMT) is performed as standard prior to conducting routine release testing. Some examples of the sample matrices that we routinely handle:-

  • Tablets
  • Capsules
  • Powders and granules
  • Syrups
  • Creams, Ointments & Gels
  • Oral and topical liquids

Dissolution

We offer both chemical and microbiology testing services,including: -

  • Disintegration
  • Dissolution
  • Hardness
  • Friability
  • Dimensions
  • HPLC - UV, RI, DAD and fluorescence detectors
  • Gas Chromatography FID and Headspace
  • Ion Chromatography
  • Compendial analysis (BP, EP, JP and USP etc.)
  • Complete microbiological testing including total viable counts (TVC) and pathogens, microbial identification, preservative efficacy testing (PET), bacterial endotoxin (LAL) testing

Through our extended ALS laboratory network and partnerships we are able to offer the following additional testing service to support your needs:-

  • Sterility
  • Elemental Impurities by USP <233> using ICP-MS
  • Microbial Identification by DNA sequencing

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