Achieving a controlled particle size distribution of your drug substance to meet your specification is critical, particularly when it’s time to scale up for manufacturing. After all, the particle size affects not only the performance, or bioavailability, of the drug substance but also its processability.
One key to success is being confident in the reliability of your laser diffraction particle size method. To do this you should know answers to questions such as:
- How do I develop my particle size method to be reliable?
- What is the best method validation strategy for my sample?
- Where do guidelines such as ICH Q14 fit into this?
- Even after you have mastered your method, there is the subject of data integrity…
Fortunately, the new Mastersizer 3000+ has you covered with its class-leading sizing capabilities and added intelligence, to help you:
- Develop an optimal method and get validation ready with Data Quality Guidance and SOP Architect.
- Gain additional confidence in your measurements with Size Sure, using the patent pending Adaptive Diffraction.
- Be assured of data integrity with the OmniTrust software platform.
発表者
- Paul Senior - Product Manager, Malvern Panalytical
- Daniel Mangel - Field Applications Scientist, Malvern Panalytical
詳細
Who should attend?
- Pharmaceutical scientists working in process development and process optimization
- Pharmaceutical scientists in particle size method development at all stages of the pharmaceutical development pipeline
- Anyone developing processes for development of Active Pharmaceutical Ingredients (APIs)
What will you learn?
- Learn about ICH Q14 guidelines for analytical development and how they apply to laser diffraction
- Explore how ICH Q2 has changed and how your validation strategy should evolve with it
- Discover how OmniTrust supports you when working in a regulated environment in accordance with 21CFR