A (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide active pharmaceutical ingredient (API) in detail. Different forms of (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide DMFs exist exist since differing nations have different regulations, such as (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide DMF submitted to regulatory agencies in the US is known as a USDMF. (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide USDMF includes data on (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (1?,2?,4?,5?,7?)-9-Butyl-7-[(2S)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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