一种测定铁剂中苯酚含量的理化检测方法研究OA

Phenol serves as a bacteriostatic agent in iron dextran injection,but its toxicity necessitates strict control at the minimum effective concentration.Currently,methods for determining phenol content in iron dextran are limited and involve high detection costs.A combined back-titration method for impurity removal by iron-sodium dihydrogen phosphate precipitation was established for the physicochemical detection of phenol content in iron dextran injection/solution.The results showed that the phenol concentration had a good linear relationship within the range of 1.25～16.95 mg/mL.Taking the amount of phenol added(mg)as the abscissa and V0-V(mL)as the ordinate,the regression equation was y=0.1565x-0.0158,r=0.9995.The recovery rate was 95.7%～104.0%.The precision relative stanfard deviation(RSD)is 0.8%.This method does not require precision instruments,is easy to operate,and has a low cost.It can meet the quality requirements of foreign customers and provide domestic iron veterinary drug manufacturers with an economical and efficient quality control means,and also offers a reference for the revision of national standards and quality and safety control of iron dextran injection/solution.