Stability monitoring of Chinese medicine reference materials

The selection of national drug standard materials requires uniform and stable quality

1.

(1) Stability conditions

The stability of reference materials is conditional and relative, and the stability of reference materials is restricted by physical, chemical, biological and other factors

(2) Stability monitoring

The stability monitoring of national drug standard materials should include whether the outer packaging is complete, whether the label is clear, whether there is any change in appearance (deliquefaction, agglomeration, precipitation, discoloration, delamination, mold and other abnormal phenomena), and should also include the labeled content and its impurities Verification of changes

(3) Investigation of indicators

The national drug standard material stability monitoring varieties should also select corresponding indicators for inspection based on the use and characteristics of the drug standard material

2.

(1) Stability monitoring of characteristic values

The national drug standard material does not specify the validity period, but the stability monitoring of the characteristic value should be carried out regularly under the specified storage and use conditions, and the traditional Chinese medicine standard material should be checked regularly to facilitate the timely detection of the change of the characteristic value and the implementation of prevention as soon as possible Measures to avoid risks, and implement the stability monitoring of standard materials of traditional Chinese medicine based on the characteristics of standard materials and influencing factors

(2) Monitoring the stability of the storage environment

The reference material will be affected by the surrounding environment, temperature, humidity and other storage conditions during the storage process, and the surface and internal changes of the reference material will occur

(3) Stability monitoring of specific varieties

The variety of stability check should also be determined according to the chemical properties of the specific variety.

3.

(1) Determination of time interval

The determination of the time interval for monitoring the stability of the standard material of traditional Chinese medicine can be determined according to the chemical characteristics of the standard material

(2) Monitoring varieties

The variety of stability monitoring should be determined according to the specific variety

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Evaluation of stability monitoring

There are three evaluation results of stability monitoring: continue to use, stop using, and recall
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1.
Continuing to use the stability monitoring results of the standard materials of traditional Chinese medicines and the labeling value are not significantly different.
When the stability and accuracy meet the requirements, the standard materials can continue to be used
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2.
Stop using When the stability or accuracy of the reference material has reached the critical level of control, the drug reference material development department should immediately take preventive measures to ensure its stability and accuracy
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3.
Recall When the difference between the stability monitoring measurement results of the reference material and the label value is statistically significant, and the stability or accuracy of the reference material has exceeded the control threshold level, the drug reference material development department must stop using the batch of reference materials
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Related links: Technical requirements for the development and calibration of Chinese medicine reference materials (2)