Intertek ASG Laboratory, Manchester, UK

Intertek ASG Case Study:

Monitoring Formulation Stability

Intertek ASG has worked with biotech and pharmaceutical clients on monitoring storage stability of amorphous and crystalline materials in formulated products (including tablets and liquids) and biopharmaceutical APIs after lyophilization or freeze drying.

Examples of relevant techniques and technologies which have been applied in a GLP environment include:

• Powder XRD for crystallinity
• Microscopy studies for crystal habit
• DSC (modulated DSC for enhanced sensitivity) for quantitative measurements of crystallinity and multiple crystalline phases

Intertek ASG scientists have been able to demonstrate the stability of crystalline materials, and the absence of occurrence of crystallisation.

asg.nwtc@intertek.com

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