Intertek ASG Laboratory, Manchester, UK

Case Study:

Analytical Method Development

Analytical Method Validation

Technology for Pharmaceuticals, Biopharmaceuticals and Intermediates

Intertek ASG experience includes provision of pharmaceutical QC and regulatory submission package support to MHRA, ICH, FDA and Pharmacopeia requirements. This has included the validation of in-house developed pharmaceutical quality control methods, method development and subsequent validation for new products or product sitings, updating and revalidation of pre-existing methods in need of revision, and support for process improvement in chemical synthesis and product formulation.

Methods have been developed and validated in the following technologies:

• Confirmation of identity by NMR, IR, MS
• Assay of components by GC, HPLC, wet chemistry
• Organic impurities by GC/MS, LC/MS, ion chromatography
• Trace elements and ions by ICP, ICP/MS, ion chromatography
• Chiral purity by NMR and chromatographies

  
A wide range of physical property measurements on products and formulations can also be carried out within Intertek ASG including, for example, viscosity (for liquid products), porosity (for marcroporous materials), and XRD (for crystalline materials).

asg.nwtc@intertek.com

+44 (0) 161 721 5247

Call Us using Skype

• ASG Laboratory Techniques
• ASG Services A-Z

• Global Intertek Locations
• Global Laboratory Capabilities