| Objective: To explore the causes of N-nitroso dimethylamine (NDMA) production in ranitidine hydrochloride drugs, analyze the problems existed in ranitidine hydrochloride products and put forward suggestions, so as to provide reference for ranitidine drug manufacturers and regulatory authorities. Methods: The NDMA test results of 230 batches of ranitidine hydrochloride drugs were statistically analyzed; The ranitidine drug manufacturers was investigated, and the research results were analyzed and suggestions were put forward Results and Conclusion: The content of NDMA in ranitidine hydrochloride API and capsules is relatively high, which is closely related to the temperature, excipients, internal packing materials and storage environment. Ranitidine enterprises have some problems, such as the NDMA control is not strict, the cause of NDMA is not clear, and the process change is difficult, so enterprises should strengthen risk control, improve the factory entry standard of API, continuously optimize the process, and reduce the production of NDMA in ranitidine hydrochloride drugs. |