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In this guidance, the term \"active pharmaceutical ingredient\" (API) (as defined in C.01A.001(1) of the Regulations) and \"drug substance\" are considered interchangeable and refers to the API used as the raw (input) material in the manufacture of a drug product. In some cases, this API may undergo in-situ conversion during the drug product manufacturing process leading to a different chemical form of the same active moiety (e.g. free acid/base form to salt form). Refer to Health Canada's Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient (June 16, 2015) for further information.
An API may be converted to a different chemical or physical form (e.g. in situ conversion of free base to salt, change of stereoisomer or polymorphic form) during the drug product manufacturing process. Such a conversion could be intended or inadvertent (e.g. processing condition in commercial lot). Nevertheless, such a conversion may adversely affect the performance, safety and efficacy of the drug product and may impact on the assessment of pharmaceutical equivalence for a subsequent-entry drug product. Instances where there is a potential for in-situ conversion based on the physicochemical properties of the API or due to the formulation and/or method of manufacture of the drug product, justification and supporting data should be provided to establish whether a conversion occurs, leading to a different physical or chemical form of the drug substance form contained in the final dosage form.
11, six in the fifth place). The emperor does not wait for a suitor to woo his daughter but gives her in marriage whenhe sees fit. Therefore it is in accord with custom for the girl's familyto take the initiative here. We see here a girl of aristocratic birthwho marries a man of modest circumstances and understands how to adaptherself with grace to the new situation. She is free of all vanity of outeradornment, and forgetting her rank in her marriage, takes a place belowthat of her husband, just as the moon, before it is quite full, does notdirectly face the sun.
To intensify the power of inner truth, a man must always turn to his superior, from whom he can receive enlightenment as the moon receiveslight form the sun. However, this requires a certain humility, like thatof the moon when it is not yet quite full. At the moment when the moonbecomes full and stands directly opposite the sun, it begins to wane. Justas on the one hand we must be humble and reverent when face to face withthe source of enlightenment, so likewise must we on the other renouncefactionalism among men. Only be pursuing one's course like a horse thatgoes straight ahead without looking sidewise at its mate, can one retainthe inner freedom that helps one onward. Nine in the fifth place means: 1e1e36bf2d