|2nd October, 2012 - 10:00 - 10:30am CET
|Raw material identification in the Pharmaceutical industry. Why and how?
It is a regulatory requirement and part of the Good Manufacturing Practice adopted by the pharmaceutical industry that each container of a raw material is identified before it's used in any pharmaceutical preparation. The Infrared spectrometer is often the first instrument that analyses a sample. Traditionally all spectra of raw materials measured by a laboratory will be compared to its registered pharmacopeial monograph.
In the simplest of terms an Infrared identification method is usually developed by constructing a spectral reference library. Essentially a collection of spectra that represent the variability that may be encountered between different batches of the materials which are included in the library.
9th October, 2012 - 10:00 - 10:30am CET
|Method development and instrument validation
Optimisation of the spectral collection is carried out so that material specific character is maximised, while anything not associated with the parameter of interest (e.g. manufacturing process, instrument, analyst, time etc) is minimised. Suitable identification algorithms are then applied to determine how similar compounds are within the library and threshold values set that can distinguish between them. Once a robust library has been created, unknown samples can be challenged against the library, if they pass the specifications set it can be assumed that they have the same characteristics as that particular group and are positively identified. There are different protocol requirements for FT-IR spectrometer compliance with The United States and European Pharmacopoeias.
16th October, 2012 - 10:00 - 10:30am CET
|Optimizing the performance of your instrument in IR Spectroscopy
It is essential that once the infrared method has been validated the instrument maintains the same operating conditions. Therefore instrument component checks are required to certify the instrument sampling module is operating correctly, and often automated instrument performance testing can be employed to ensure regulatory IR criteria are met. Additional contamination checks should be implemented to test for sample carry over.
During the lifetime of the infrared method it is essential that the results are evaluated to establish equivocal answers and confirm pharmacopieal requirements.