Research Institute for 

Pharmacy & Biochemistry

cs-CZen-GB
25 May 2019
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

The next earliest date:

Location: Brno

Course price: 

In the case of a cross-border transfer please instruct your bank to ensure that the amount payable is credited net to our account, i.e. any bank charges and commissions are charged to your own account.

If you are interested in this course please contact us by e-mail on info@vufb.eu. Thank you.

The course price is payable in advance based on a proforma invoice, which is sent electronically. The fee is to be paid within 10 days after receipt of the proforma invoice. Otherwise the booking will be released to another party. After receipt of the amount to our account your participation in the course is guaranteed.

Number of participants is limited.

After completion of the course each participant will receive a certificate verifying completion of the course.

For more details please see General Terms and Conditions of Training Organized by VUFB in the Czech Republic.

Terms and conditions for in-house courses will be agreed individually.