Zdrowie i gospodarka · 9.03.2000
Draft Guidance for Industry on Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence.'' This draft guidance is intended to provide recommendations to applicants who wish to submit a new drug application or abbreviated new drug application for a natural source conjugated estrogens solid oral dosage form. This guidance provides a description of the liquid chromatography-mass spectrometry (LC-MS) method that can