The Study And The Whole Assessment On The Quality Of Benzyl Alcohol

Objectives To evaluate the current standard quality control level of benzyl alcohol, the ability to control the process of manufacturing enterprises, the quality of benzyl alcohol and the management level about pharmaceutical excipient in manufacturing enterprises or using enterprises according to the results of current standard and the revised standard test.Methods Determining benzyl alcohol samples according to the current standard; conducting a series of studies around the quality standard controllability, and the effectiveness, stability or safety of excipients, according to the standard at home and abroad and the main manufacturing process of benzyl alcohol, including the researches of the organic impurity, inorganic impurity, other general inspection items, assay, stability and safety, and the excipients compatibility test, etc; analyzing and comparing of the different levels of the sample at home and abroad, and the different refining processes; integrating scores according to the current and revised standards respectively by comprehensive score calculation software, etc.Results The percent of pass of benzyl alcohol samples is95.5%according to the current standard. After a series of studies, a new GC method to determine related substances was established; chloride inspection item was increased; acidity which was simple and workable could be substitute for acid value which was complex as well as detrimental to environment by analyzing comparatively the two above; water inspection item was increased; GC method to detemiine the content of benzyl alcohol was established; destructive tests indicated benzyl alcohol is unfavorable compatibility with strong acid or oxidizing medicine; factors test confirmed that benzyl alcohol was photolabile, when exposing to light the impurities significantly increased; safety studies demonstrated that the bacterial endotoxin test should be increased when it used for injection; compatible experiments of clindamycin phosphate injection suggested the preparation of prescription was reasonable; the results of comparative study on the quality prompted that the impurity level of chemical analytical reagent, whether imported or domestic reagent, was higher than the pharmaceutical grade samples, the sample after refining quality was better than the quality of the sample before purification.Conclusions Benzyl alcohol was carried on the comprehensive evaluation for the first time. Current legal standard should be improve urgently and be evaluated as feasible basically, and revised standard has been submitted to the national pharmacopoeia committee; current manufacturing process or refining process of pharmaceutical grade benzyl alcohol were almost at the same level, however, chemical grade benzyl alcohol could not be substituted for pharmaceutical grade reagents, and the quality of the product could be improved by refining; the quality of benzyl alcohol samples were evaluated as relatively good; the management of manufacturing enterprises or using enterprises about pharmaceutical excipient should be strengthened.