Research Institute for 

Pharmacy & Biochemistry

13 July 2020
Course description

Setting parameters of APIs and drug formulations with regard to polymorphism and optical purity

The course acquaints with the content of and the latest amendments to principal ICH quality guidelines. Guidelines pertaining to impurities, Q3A(R2), Q3B(R2) and Q3C(R3), and guideline Q6A dealing with specifications with main focus on optical purity and polymorphism are considered in more detail. Preformulations problematics is briefly presented. The course also deals with drug polymorphism in terms of description of polymorphism, pseudopolymorphism and amorphous substances and in terms of patent law aspects connected with polymorphism. Analytical techniques used for polymorphism screening are reviewed. In connection with guidelines dealing with impurities, aspects of R&D and production of chiral APIs are discussed, including analytical methods that can be used for determination of optical purity.

The course is run by experienced lecturers Assoc. Prof. Jiri DohnalDr. Tatjana Grafnetterova and Assoc. Prof. Josef Jampilek who concern themselves with this problematics for many years and lecture on similar topics within other educational programmes.

More details

Date: in the plan

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Location: Brno

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Number of participants is limited.

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