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This direction is not meant to define registration and/or submitting requirements or modify pharmacopoeial requirements. This assistance does not impact the flexibility from the accountable regulatory agency to determine specific registration/submitting prerequisites pertaining to APIs inside the context of promoting/manufacturing authorizations or

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detector based on particular residence of eluting molecules which is impartial of improvements inside the cell section compositionThe objective substantial perfomance liquid chromatography (HPLC) analysis of any medicines is to confirm the identity of a drug and supply quantitative results as well as to observe the development with the therapy of a

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