Method for detecting vitamin B6 residual solvent

Abstract

The invention provides a method for detecting a vitamin B6 residual solvent and belongs to the technical field of medicine production. The method is used for solving the technical problem that the existing vitamin B6 residual solvent detection is high in error. The method for detecting the vitamin B6 residual solvent comprises the steps: firstly, preparing a solution, then, carrying out a system adaptability test, carrying out blank solution needling, then, sequentially injecting six needles of system adaptability solution, two needles of standard substance test solution, one needle of testee solution, one needle of testee solution and one needle of standard substance test solution, separately recording chromatograms, and analyzing the chromatograms, thereby obtaining the content of residual solvent in a detected sample. The method has the advantages of low error, little environment and equipment influence, and the like.

Description

technical field

[0001] The invention belongs to the technical field of pharmaceutical production and relates to a method for detecting vitamin B6 residual solvents. Background technique

[0002] The new version of GMP has requirements for residual solvents, and vitamin B6 export foreign trade customers also have relatively high requirements for residual solvents. Moreover, residual solvents basically need to be tested. We used a Denny HSS86.50 headspace sampler and a GC-2014 Shimadzu gas chromatograph.

[0003] Headspace gas chromatography is a combined operation technique, which usually uses a sample needle to extract and adsorb solids, liquids, gases, etc. under certain conditions and a certain temperature, and then desorbs and injects them on a gas chromatograph.

[0004] The method of using the pure product of the component to be measured as the reference substance and comparing the response signal of the reference substance with the component to be measured in the samp...