Method for preparing organic solvent-free lyophilized cyclophosphamide
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United States of America Patent
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Jul 25, 2023
Grant Date -
Jun 17, 2021
app pub date -
Apr 11, 2019
filing date -
Apr 13, 2018
priority date (Note) -
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Abstract
The present invention relates to a method for preparing a lyophilized cyclophosphamide composition, wherein 99% or more of the finally prepared lyophilized cyclophosphamide composition is reconstituted within 15 seconds when water for pharmaceutical use is injected thereinto at a ratio of 50 mL per 1 g of anhydrous cyclophosphamide, comprising a step of dissolving D-mannitol or lactose, as a lyoprotectant, and cyclophosphamide in a water solvent in a selected reaction vessel; and a lyophilized cyclophosphamide composition for injection prepared thereof.
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