Extractable Leachable Practical Course. How to Apply USP Requirements to Design and Execute Extractable and Leachable Studies
The workshop will discuss different analytical approaches related to extractable and leachable testing. Practical recommendations will be presented for designing and executing controlled extractions. Analytical solutions will be explained according to the latest regulatory expectations. The workshop will provide practical guidance and case studies from start to completion.
– Bench Scientists who are would like to gain expertise and knowledge for trace analytical methods and advanced sample preparation.
– Regulatory persons
The following topics will be covered:
– Design of extractable studies
– Importance of the AET, how to calculate the AET based on the formulation and the dose of the finished product.
– Extraction studies, practical guidance, solvent based and non-solvent based extraction techniques
– Practical aspects for selection of extraction time and extraction temperature
– What to do if the extracts need to be concentrated
– Compatibility of extraction solvent of choice and analytical instrumentation
– Comparison of solvent based and solventless extraction techniques
– Static head-space, dynamic head-space, Solid Phase Microextraction and Twister will be explained with their unique drawbacks and benefits
– Extraction approaches will be presented for inhalation, injectables, large volume parenterals, transdermal products, and medical devices
– Choice of analytical techniques for characterization of the extracts
– The drawbacks of “one size fits all” practice
– Short practical guidance regarding different mass spectrometry techniques
– Component identification practice according to USP <1663>
– Method validation practice
– How to design appropriate validation protocol for ppm, ppb and ppt level?
– How to define and justify appropriate acceptance criteria for low level testing.
– Method requirements specific to mass spectral based methods
Dr. Gyorgy Vas has M Sc in Analytical Chemistry and a Ph. D. in Mass Spectrometry. He had published 18 research papers that have been cited more than 2500 times. Dr. Vas has several years of experience in E&L testing, pioneering and adopting solventless analytical sample preparation techniques. He has multiple years of experience for developing trace level analytical methods and validating methods at trace level. He worked for Johnson & Johnson for 7 years and was recipient of Johnson & Johnson Outstanding Analytical Scientist Award and the Philip B. Hofmann Research Award. Currently he is holding position in Intertek as a Business-technical Scientific Liaison.