The chemical composition of the active ingredient of a pharmaceutical dosage form determines the efficacy and stability of the formulation however during manufacturing it is the physical properties of the formulation components that are critical in the unit operations. In order to evaluate the physical properties of a solid it is important to have reliable and reproducible analytical techniques. However the techniques available are not as direct and unambiguous as the chemical techniques available for purity, impurities etc. This seminar will provide an introduction to these physical analytical and screening techniques, the desired ranges and suggestions concerning their application.
Why you should attend: In my 31 years experience in the pharmaceutical industry I would estimate that 95% or more of the manufacturing problems that I have encountered had nothing to do with the chemical composition of either the active ingredient or the excipients but rather were do to a poor understanding of the physical properties of the formulation components. A thorough understanding of the drug's physical properties requires analytical that can reliably detect changes and/or inconsistency in the physical properties of the solids involved. In many cases there is no direct approach to measuring the particular property so their values must be obtained indirectly.
Areas Covered in the Session:
* Introduction to Physical testing techniques
* Should there be specifications for physical properties
* Crystallinity testing
* Polymorph identification and quantization
* Particle size techniques
* Surface area determination
* Moisture content
* Data interpretation
* Method Validation
Who Will Benefit:
* Synthetic Chemists
* Process Engineers
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