It is recommended to refer to the requirements for long-time testing of pharmaceutical products in “Guidelines for the Stability Test of Drug Substances and Products” in “Pharmacopoeia of the People’s Republic of China” to submit the stability verification data of concentrates and determine the shelf life of the product based on the results.
In the process of stability verification, it is necessary to observe the products of all models and packing volumes. According to the actual situation of the product, determine the appropriate conditions of the storage, transportation and packaging, and the storage condition of temperature and humidity in the south or north expected, check for the stability of the concentrate at different assessment time points.
The observation items should include all performance in technical requirements and analysis of chemical contaminants. It is also necessary to provide the test results of such items as solute concentration, insoluble particles, microbial limit (or sterility), and endotoxin of the concentrates at different assessment time points in accordance with the technical requirements. For dry powder, the comparison result of dissolution time should be added. For the dry powder B products for online use, the test results of ion concentration and pH at four time points at least (at the beginning of dialysis, the two time points for three equal division of the clinical use duration, at the end of dialysis) should be additionally provided. For the analysis of chemical contaminants at different assessment time points, it is recommended to refer to the test indicators in YY 0572. The chemical ions already contained in the component raw materials are not required for testing.
