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    Home > Chemicals Industry > Chemical Technology > Stability monitoring of Chinese medicine reference materials

    Stability monitoring of Chinese medicine reference materials

    • Last Update: 2022-06-22
    • Source: Internet
    • Author: User
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    The selection of national drug standard materials requires uniform and stable quality
    .
    According to the practice of international drug reference material management, currently there is no “validity period” for Chinese medicine reference materials, and the China Inspection Institute conducts stability monitoring of Chinese medicine reference materials

    .

    1.
    Stability Monitoring Project

    (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
    .
    The factors that affect stability include physical factors such as light, temperature, and humidity; chemical factors such as dissolution and decomposition, and biological factors such as bacterial action, and these different influencing factors affect each other

    .

    (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
    .
    Effects can select test items of value, such as moisture, determination of related substances, and the like potency

    .

    2.
    Stability monitoring objects

    (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
    .
    These changes affect the quality of standard materials.
    Stability monitoring can be carried out for standard materials that have been stored for a long time, such as deliquescent, agglomeration, precipitation, discoloration, delamination, moldy outer packaging and other abnormal phenomena

    .

    (3) Stability monitoring of specific varieties

    The variety of stability check should also be determined according to the chemical properties of the specific variety.
    For example, the chemical reference substance of traditional Chinese medicine for content determination should first consider the changes in moisture and impurities that will affect the fixed value

    .

    3.
    Stability monitoring schedule

    (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
    .
    Stability monitoring can be arranged in accordance with the principle of density first, sparseness later, and the verification interval of different reference materials can be found to determine the verification interval

    .

    (2) Monitoring varieties

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

    1.
    The first batch of traditional Chinese medicine reference materials should be checked at least once a year until complete stability data is obtained

    .

    2.
    The inspection period should be determined based on the previous standardized data for the changed batch of varieties

    .

    3.
    Unstable varieties.
    The unstable varieties of national drug reference materials should be checked once a year.
    For national drug reference materials that are prone to oxidation and photolysis, nitrogen filling and brown ampoule packaging can be used as far as possible to pack in order to increase stability

    .

    4.
    Multiple varieties with undetermined characteristic values ​​When the reference material has multiple undetermined characteristic values, those variable and representative undetermined characteristic values ​​should be selected for stability monitoring

    .

    4.
    Evaluation of stability monitoring

    There are three evaluation results of stability monitoring: continue to use, stop using, and recall
    .

    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

    .

    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

    .

    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

    .

    Related links: Technical requirements for the development and calibration of Chinese medicine reference materials (2)

     

     

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