Vitamin C Injection Quality And Safety Standards

Objective:This issue through the optimization of the injection method forthe determination of vitamin C, color change and related substances,the imperfections of the existing Pharmacopoeia improvements, andto carry out the Vitamin C Injection quality and safety standards,and aims to establish simple and quickvitamin C Injection physicalsecurity standards and to identify vitamin C Injection easy to turnyellow root cause. Eventually establish a perfect quality controlstandards, and provide a strong guarantee for the clinicalmedication safety.This experimental study:1. Vitamin C injection related substances preliminary study.①injection of vitamin C substances detection methods, theestablishment of a Waters e2695: Inertsil amino Column, mobilephase of0.05mol/L potassium dihydrogen phosphate-acetonitrile(30:70), detection wavelength of210nm, flow rate1.0ml/minThecolumn temperature was30℃,Injection10ul.②vitamin Cinjection material and color change, measurement methods take Ⅰplant vitamin C injection, air exposure, vitamin C injectionstandard colorimetric solution No. contrast, made1-7differentcolor number lines. Each exposed to a color number, with UV500UV-visible spectrophotometer and Waters e2695high performance liquid measured absorbance and related substances.2. Vitamin C Injection of exploration and study of the structureof the colored substances①current phase: ammonium acetate(0.01mol/L, adjusting the pH value to6.8with aqueous ammonia)-acetonitrile (24:76); detection wavelength: UV detector210nm,column temperature:30°C; flow rate:1.0ml/min.②Vitamin CInjection related substances LC-MS/MS conditions to explore:Venusil HILIC column (250mm×4.6mm,5μm); mobile phase:0.01mol/L ammonium acetate-acetonitrile (60:40), flow rate:0.4mL/min, injection volume:20ul3. Optimization of the injection method for the determination ofvitamin C, Phenomenex Luna-NH2analytical column (4.6mm×250mm,5μm), the mobile phase was0.05mol/L potassium dihydrogenphosphate solution-acetonitrile (30:70), detection wavelength of266nm,flow rate of1.0ml/min, column temperature30°C, theinjector10ul injection of vitamin C content was measured andcompared with the traditional iodine titration.4. Vitamin C Injection Pharmacopoeia method supplemented with①For substances testing and regulations. Total impurity and thesingle largest impurity limited b vitamin C injection relatedsubstances detected.②optimization of vitamin C injection method for the determine-ationResults:1.①Total impurity content shall not exceed1.0%limit, thesingle largest impurity not more than0.3%limit.②find6.6minwith vitamin C injection color deepened and increased substance,this is the main reason for the yellowing of vitamin C injection, it is in a position to do further research, LC-MS/MS its explore.2. Impurities in the sample can be well detected each impurityseparation between the main peak of the substance on the method forvitamin C and its degradation product formation macromolecules.3. Measured by HPLC injection of vitamin C content than the iodinetitration method measured the content of1%lower on average,followed in order to ensure safety, some samples should besubstandard treatment, but the iodine titration in the qualifiedrange, it is suggested thatHPLC to replace the traditionaliodometric titration to determine the content of vitamin Cinjection4.①a.proposed total impurities not more than1.0%of the extentto which, and the single largest impurity limits should not exceed0.3%. b. recommendations absorbance of not more than0.03.②an alternative to traditional HPLC iodometric titration...