Primary reference standard active compound

Primary reference standard of the active compound. The standard of an active compound is typically comprehensively characterized. Table 3 lists the detail required. 

Related compound standard. These standards are typically characterized fully, but not to the same extent as the primary reference standard of the active... 

A detailed qualification report is drafted for a primary reference standard of the active compound less comprehensive documentation is typical of the other standards. Portions of this report may be submitted to the regulatory authorities. The report references the synthetic route for the standard and any purification schemes that were utilized in preparing the pure standard. Other components of this report may include the following ... 

Related compound standard These standards are typically characterized fully, but not to the same extent as the primary reference standard of the active drug substance. Because quantities of these standards are typically limited, response factors for these standards can be assigned to eliminate routine use in FIPLC purity determination. 

Compound 4 was suspended in poly(methyl methacrylate) (PMA) and then cast into a thin film. The "polymer solution" of 4 was then subjected to corona poling at elevated temperature. The poling process afforded a polymer film which exhibited significant SHG (Scheme III). Using a primary frequency of 1064 nm the SHG band at 532 nm i.e. green light) was visible to the naked eye. At this time there were no reference standards available for quantification of the data. After standing for several days the film showed little, if any SHG activity. 

High-purity materials are available as pure solids for chemical uses such as metals used as reference substances for metallurgical analysis, and compounds used as primary standards for many types of titrimetry, and as standards for elemental microanalysis. Other available high-purity substances intended for diverse physical properties include ion activity standards for the calibration of pH and ion-selective electrodes standards for various thermodynamic uses including melting point determinations, differential scanning calorimetry and bomb calorimetry and standards for the calibration of spectrophotometers. 

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