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Method Development and Validation for Particle Size and ...
Method Development and Validation for Particle size and Shape Measurements Ulf Will n Divisional Product Manager Analytical Imaging Systems Malvern Instruments Ltd, Malvern, UK. FDA guidance: when should Particle size be measured? International Conference on Harmonization;. Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances*. New Drug Substances (b) Particle size : For some new drug substances intended for use in solid or suspension drug products, Particle size can have a significant effect on dissolution rates, bioavailability, and/or stability.
“The normal concepts of validation may differ for particle size methodologies as compared to other analytical methodologies such as HPLC.” “… the system should be calibrated according to the
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