HPLC Instrumentation Design Principles

MODULAR HPLC INSTRUMENTATION FOR SEPARATION OF SMALL MOLECULES DESIGN PRINCIPLES AND SPECIFICATIONS FOR EACH MODULE... 

The basic theory, principles, sensitivity, and application of fluorescence spectrometry (fluorometry) were discussed in Chapter 8. Like the UV absorption detector described above, the HPLC fluorescence detector is based on the design and application of its parent instrument, in this case the fluorometer. You should review Section 8.5 for more information about the fundamentals of the fluorescence technique. 

Description of the Scientific Principles of the Method and the Critical Reagent or Instruments Used in the Method. The design of validation tests will depend on this information. For example, if uniquely derivatized solid phase high (HPLC) support was used in the method, this would be classified as a modification to existing technology. As such, the developer of the method should demonstrate that the technique of preparing the HPLC media is well understood, is reproducible and will yield batch-to-batch uniformity. 

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