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Analytical Chemistry in the Pharmaceutical Industry

Course Dates: 12 & 13 May 2009   to be re-scheduled     Venue:

Cost: £1160 + VAT

Analytical chemistry underpins pharmaceutical drug development by providing assurance of the quality, safety and efficacy of new medicines. This course is an overview of the areas in which analytical chemistry plays a vital role in developing a new drug. There is a focus on HPLC as being the most important analytical procedure in today’s pharmaceutical industry, but other techniques are also covered, for instance those used to investigate polymorphism in new drugs. The applicability of regulatory guidance, particularly that from ICH, to analytical chemistry is also covered in this course.

This course will benefit managers with a responsibility for analytical chemists. It is also recommended for project team members working alongside analytical chemists, as well as analysts requiring a broad overview of their role in the pharmaceutical industry. While covering a range of techniques, emphasis is also placed on the

responsibilities of the analytical chemist to deliver reliable data in compliance with appropriate regulatory guidance.

The course will cover:

• Drug characterisation
    -proof of structure
• Drug quality: testing for:
    -purity
    -assays
    -manufacturing impurities
    -degradation products
    -isomers (inc. stereoisomers and enantiomers)
    -existence of polymorphs
• Stability testing

• Techniques used by the analytical chemist
    -Typical procedures used for drug substance (API) testing
    -Typical procedures used for drug product testing
• Focus on HPLC
    -Introduction to HPLC and basic method development
    -Techniques used in quantitative analysis by HPLC (including internal and external standardisation)
    -unresolved peaks)
    -Calculations in HPLC analysis
    -Understanding the results (special focus on measurement by ‘relative peak area’ and conversion to

            relative mass).

• Reference standards
    -Their use
    -Maintenance of a reference standards system
    -Frequency of testing reference standards
    -Replacement of expired reference standards

• Staging of analysis (doing an amount of work that is appropriate to the phase of development of the drug)
• Validation of analytical methods
• Regulatory guidance
    -Introduction to relevant ICH guidance documents
• Presentation of results (and CTD format)
• Specifications …. and dealing with Out-of-Specification results
• Technology transfer of analytical methods
  

Speaker:

Dr Roland Collicott