Services   contd.

Examples of areas where Dave Murphy can provide analytical chemistry consultancy services are:-

• method development and validation for synthetic intermediates and the final drug substance
• supporting solid state characterisation studies, salt form selection and polymorph screening of drug substance
• pre-formulation and excipient compatibility studies
• development and validation of methods for a wide range of formulated products
• troubleshooting analytical method problems
• supporting the development of formulations for toxicology studies and clinical use
• supporting investigations into synthetic impurities and degradation products
• chemical stressing, short term and long term ICH stability studies and shelf life setting
• generation of batch analysis data, certificates of analysis and stability summaries
• reference standard characterisation
• setting specifications for drug substance and formulated products
• release testing of materials for pre-clinical and clinical use
• support in the preparation of CMC regulatory documents

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