5 results about "Stability indicating" patented technology

The invention provides a method for detecting related substances in piperacillin sodium. The octadecyl silane bonded silica gel chromatographic column is adopted for gradient elution, and quantitative detection of 25 impurities in piperacillin sodium is rapidly and accurately achieved by optimizing chromatographic column filler and specification, mobile phase concentration, gradient elution conditions and the like. Detection results show that all related substances are well separated from the main component piperacillin. Through methodology verification, the detection method provided by the invention has the advantages of high separation degree, accurate result and good stability, can realize detection of 25 impurities in piperacillin sodium within 33min, and can significantly improve the detection efficiency and reduce the detection cost. The 25 impurities cover related substances in the production, storage and stability test processes of piperacillin sodium. The detection method can be used as a stability indication method of piperacillin sodium, is used for quality control of piperacillin sodium, and has a wide application prospect.

The application discloses an analysis method of tobramycin sulfate injection and application thereof, and the analysis method comprises the following steps: performing a pre-column derivatization reaction on a sample containing tobramycin and impurities by using a derivatization reagent, and then performing high performance liquid chromatography analysis on the sample after derivatization. The analysis is performed by gradient elution of a mobile phase A and a mobile phase B composed of water, acetonitrile and phosphoric acid, wherein the content of acetonitrile in the mobile phase B is higher than that in the mobile phase A, and effective separation of tobramycin and related impurities is realized by multi-stage gradient elution. The method can simultaneously separate and detect process impurities, degradation impurities and unknown impurities, has good separation degree and stability indicating capacity, and is suitable for quality control and drug stability research of tobramycin sulfate injection.

The invention relates to a method for detecting the activity of human chorionic gonadotropin (hCG). A CHAPS solution is used as a sample diluent of hCG, and a lower first-hole concentration can be used. The method has good drug specificity and cell specificity, good stability indication property, small intermediate precision coefficient of variation, high average recovery rate, a linear fitting correlation coefficient close to 1, and a moderate relative activity detection range (e.g., 50% to 200%). The method can realize accurate and sensitive testing of the biological activity of hCG, and provides a key technology for quality control of drug production.

The invention discloses an analysis method for determining related substances in melogabalin besylate tablets, which establishes an analysis method with high detection sensitivity, high specificity, high accuracy and a stable indication effect by optimizing chromatographic conditions, optimizing the types of solvents and additives of mobile phases and adopting gradient elution. And good applicability and operability of the analysis method in the quality control application of the product are facilitated.

The invention relates to the technical field of gas chromatographic analysis, in particular to a method for determining the residual quantity of methyl iodide in a riociguat raw material by adopting GC (Gas Chromatography), which comprises the following steps: treating a sample by adopting a capillary column taking polyethylene glycol as a stationary liquid and adopting a mode of taking an organic solvent to dissolve the riociguat raw material and then adding water, so as to determine the residual quantity of methyl iodide in the riociguat raw material. A hydrogen flame ionization detector is adopted to determine the residual quantity of iodomethane in the riociguat bulk drug. The method has the following beneficial effects that the sample solubility is good, the recovery rate is high, the specificity is good, the sensitivity is high, the accuracy is good, the durability is good, and the stability indication capability is good.