analytical standards of the pure active substance

analytical standards of the pure active substance

(c) the content of the pure active substance in the manufactured material;

For the repeatability in the determination of the pure active substance in principle a minimum of five determinations must be made. The relative standard deviation (% RSD) must be reported.

Representative samples of the active substance must be analyzed for content of pure active substance, inactive isomers, impurities and additives, as appropriate.