Monographs standards development process

The Standard-Setting Process. Settiag USP-NF standards is a continuing, and by no means unilateral, process. The Committee of Revision not only develops monographs for new substances but also continually reviews the monographs, specifications, and testing methods for existing substances. Results are pubHshed in one or more supplements each year. A complete review is done every five years and a revision is pubHshed. 

While compendial standards are available for some monographed article impurities, it may be difficult at times to obtain pure standards of impurities. Manufacturers of pharmaceuticals function as a potential source for obtaining reference standards of impurities, which may be synthesis precursors, process intermediates, or degradation products. The characterization and evaluation of these impurities reference standards should be constant with their intended use. In many cases, analytical procedures are developed and validated, where the response of an impurity is compared to that of the new drug substance itself. Response factor evaluation of impurities at the chosen detection wavelength is necessary to determine if a correction factor is needed (when the responses differ). Potentiometric detection, fluorescence/ chemiluminescence detection, and refractive index detection are some examples of detection modes available for compounds that may not be suitable for UV detection. 

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