1?Standard substance preparation laboratory, clean room should be in line with China's "Good Manufacturing Practice" or "Laboratory Practice" requirements.
2?The preparation and calibration of national standard substances is the responsibility of the National Institute for Drug Control.
3?Development of new standard substances
(1) Selection of raw materials
The raw materials for the preparation of standard substances for biological products should be homogeneous with the test article, should not contain interfering impurities, and should have sufficient stability and high specificity, and sufficient quantity.
(2) standard substance preparation, dispensing, lyophilization and fusion sealing
According to the requirements of various standard substances for preparation, dilution. Need to add protective agents and other substances, such substances should have no effect on the activity and stability of the standard substance and the process of test operations, and its own drying in the non-volatile.
After passing the general quality check, the precise dispensing, the accuracy should be within ±1%.
Those requiring dry storage shall be lyophilized and melt-sealed immediately after dispensing. Unless otherwise specified, the moisture content of the lyophilized shall be less than 3%.
The process of dispensing, lyophilization and fusion sealing of standards should ensure that there is no effect on the consistency of potency and stability among ampoules.