Reference Substances Used for Identification

The batch must comply to the requirements of the monograph. However, the most important control is the application of the test(s) for which the substance is intended. It is usual for at least one laboratory (usually the Ph. Eur. laboratory) to apply all tests of the monograph. The structure of the substance must be clearly identified by comparison of the IR spectrum to spectra published in the literature and interpretation of the NMR and mass spectral data. 

2 Reference Substances Used for Related Substance Tests 

As previously described three types of reference substances may be used in this test  

The substances described under (i) and (2) are characterized by the following physico-chemical and spectrophotometric techniques  

Although not used for assay purposes, the purity of the CRS should be at least 90 %. However, when the substance is used in a quantitative test and the purity is not greater than 99 % a content will be assigned. 

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