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The characteristic value is the basis of drug reference materials.
1.
The following information should be submitted in the research report of Chinese medicine reference materials:
1.
2.
3.
4.
5.
6.
2.
On the basis of meeting the current quality standards, the raw material candidates should have sufficient quantity to meet the needs of distribution and use; and should have sufficient stability
3.
The preparation site, preparation process, sub-packaging accuracy, and sub-packaging process of drug standard materials should meet the characteristics of the variety; the number of collaborative calibration units and the data of collaborative calibration meet the requirements for the varieties to be calibrated collaboratively
Fourth, the accuracy of the quality value of drug standards
The quality value of drug standards should be traceable
5.
