Analytical Services: Overcoming challenges in particle size measurement by laser diffraction technique
Event: Landolakes Confernce – Strategies for Analytical Excellence
Speakers: Kalyan Poturi, Noel Hamill, Catherine McClorey and Linda McCausland
Introduction:
Increasing numbers of API’s are being discovered through use of high throughput screening, leading to larger lipophilic molecules with poor solubility characteristics. Therefore, the impact of particle size on bioavailability has become much more important and as a result, the particle size distribution of API is a critical quality attribute for many new drugs. The poster details some parameters and conditions that should be considered during method development and validation for particle size distribution assessment by laser diffraction. This is illustrated by a case study where a single method was developed for both API and drug product for a drug with particle size distribution as a critical quality attribute.
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Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.