lexiara

anx_II__cpt_1__point_7__text_1

Where testing is done, a detailed description (specification) of the active substance used and its impurities must be provided. Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.