Kit for detecting dicysteine related substances
A technology for dicysteine and related substances, which is applied in the field of kits for detecting dicysteine-related substances, can solve the problems of no rapid detection of dicysteine, and achieve low and high detection and quantification limits. System applicability and specificity, the effect of baseline stability
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Embodiment 1
[0057] This embodiment provides a kit for detecting dicysteine-related substances, including amino derivative reagent solution, borate buffer, diluent, stop solution, and related substance standard solution, wherein,
[0058] The amino derivatization reagent solution is 1.25 mg / mL of 9-fluorenylmethyl chloroformate solution, the solvent is acetonitrile, 500 μL each;
[0059] The borate buffer solution is 0.1mol / L, pH is 8.5, 250 μL each;
[0060] The diluent is a solution with a volume ratio of acetonitrile and water of 1:1, 500 μL each;
[0061] The stop solution is 20vol% acetic acid solution, and its solvent is 500 μL of the dilution solution.
[0062] The related substance standard solutions are cysteine solutions with concentrations of 0.6, 0.9, 1.2, 1.8, 2.4, 3.6 and 12.0 μg / mL and concentrations of 0.3, 0.45, 0.6, 0.9, 1.2, 1.8 and 6.0 μg / mL tetrahydrothiazole-4-carboxylic acid solution, the solvent of the related substance standard solution is water.
[0063] The...
Embodiment 2
[0072] This embodiment provides a method for detecting related substances in dicysteine, using the kit in Example 1, and the specific steps are as follows:
[0073] (1) Prepare the sample solution to be tested: take 1 bottle of dicysteine for injection (containing 1.5 mg of dicysteine) produced by Jiangyuan Pharmaceutical Factory of Jiangsu Institute of Atomic Medicine, add 1 mL of water to dissolve and mix, and take 400 μl , diluted to 1mL with water, and mixed to obtain the sample solution to be tested;
[0074] (2) Carry out amino derivatization of the sample solution to be tested: take 250 μL of the sample solution to be tested, add a borate buffer solution, mix well, add a solution of amino derivatization reagent, vortex immediately for 120s; add one to stop solution and a diluent, continue to vortex for 120s, and filter through a 0.45μm organic membrane to obtain the derivatized sample to be tested;
[0075] (3) Inject the derivatized sample to be detected into the ma...
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