Patent classifications
G01N2030/645
Method for the detection and quantification of fosfomycin, impurities and degradation products thereof
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.
CHROMATOGRAPH SYSTEM
A chromatograph system includes a liquid delivering pump that delivers a mobile phase, an autosampler that injects a sample into the mobile phase downstream of the liquid delivering pump, a separation column that is located downstream of the autosampler and separates components in the sample injected into the mobile phase by the autosampler a detector that has a detector cell provided downstream of the separation column and detects components in the eluent flowing through the detector cell, a plurality of sensors that measure physical quantities related to the chromatograph system, an analyzability determination unit that, during an analysis preparation period for performing sample analysis, determines whether or not the chromatograph system is in an unanalyzable state in which a detector signal output from the detector deviates from a threshold range set for the output signal during a predetermined time, and a cause identification unit configured to, when the analyzability determination unit determines that the chromatograph system is in the unanalyzable state, and when the sensors include an unstable sensor that outputs a value determined to be in an unstable state based on a preset criterion for each of the sensors, present information related to the unstable sensor to a user as a cause of the unanalyzable state.
COMBUSTION GAS ABSORPTION LIQUID GENERATION DEVICE AND COMBUSTION ION CHROMATOGRAPH
A combustion gas absorption liquid generation device includes a supplier, a combuster that generates a combustion gas by combusting and decomposing a sample, and an absorber that causes an absorption liquid to absorb the combustion gas generated in the combuster. The supplier supplies the sample supplied from a sample supplier to the combuster, and supplies the absorption liquid supplied from an absorption liquid supplier to the absorber.