Quality Control Of Ibuprofen Oral Solution In The Process

In the thesis the quality control of ibuprofen oral solution in the process of the generic process was studied,which should be consistent with the listed products and the security of the generic drug is not less than the listed products.The oral solution of ibuprofen was studied, in which reflecting the effectiveness of the key index was the content, reflecting the main indicators of safety was the various quality comparison, namely relevant material. By analyzing relevant literature, listed product instructions, and chromatographic detection method about Ch. P-2010, EP8.0, WS1-(X- 003) – 2002 Z of ibuprofen, and considering with the characteristics of preparation, the method for determination of the preparation content and related material were established. With this method, the impurities in the API and the quality of raw materials were analyzed.The key control on preparation technology of ibuprofen oral solution in the process was studied: i.e. heating time, heating temperature, sterilizing conditions, total mixing time, potting process parameters. The results indicated that the optimal conditions in the preparation process are the heating time of 5min, heating temperature of 60℃, and non-sterilizing process.The critical process parameters were modified in the pilot scale production, which were validated by three batches of industrial production. All results tested showed that the basic index of the products was stable and consistent, concluding product character, p H, content, taste and relevant material, and the product quality was unchanged.Finally, the accelerated test of 0, 1, 2, 3, and 6 months, long-term stable experiment of 0, 1, 2, 3, 6, and 9 months, and the stability of ibuprofen oral solution was evaluated with influencing factors in the experiments. The results showed that the traits, clarity, p H value, content, and relevant material met the quality control, and theproduct had good consistency.By the process controlling of quality the product in the preparation process is stable and feasible. The quality standard and the stability studies were completed. These results provide more experimental basis for further investigation and lay good basis for further manufacture.