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AssigneeMeitheal Pharmaceuticals, Inc.
InventorsRobert Divasto, Marta Mariño
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The present invention relates to a method for the detection and quantification of fosfomycin and impurities and/or degradation products thereof in samples of fosfomycin or a pharmaceutically acceptable salt thereof or in pharmaceutical compositions comprising fosfomycin or a pharmaceutically acceptable salt thereof. The present invention further relates to a process for manufacturing fosfomycin, or a pharmaceutically acceptable salt thereof having a specified purity degree, as well as to the fosfomycin or a pharmaceutically acceptable salt thereof as obtained. The present invention further relates to a process for manufacturing a pharmaceutical composition comprising fosfomycin or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient having a specified purity degree, as well as to the pharmaceutical composition as obtained.
A method for the detection and quantification of fosfomycin, impurity A, and at least one additional impurity in samples either including fosfomycin or a pharmaceutically acceptable salt thereof or including pharmaceutical compositions comprising fosfomycin or a pharmaceutically acceptable salt thereof, wherein the method comprises:
Dependencies are inferred from the claim text.