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    Home > Chemicals Industry > Chemical Technology > Visible foreign body inspection of Qingkailing injection and Shuanghuanglian for injection (lyophilized)

    Visible foreign body inspection of Qingkailing injection and Shuanghuanglian for injection (lyophilized)

    • Last Update: 2022-06-15
    • Source: Internet
    • Author: User
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    Visible foreign body inspection of Qingkailing injection

    test record

    Illumination: 2000-3000x

    Specification: 10ml each

    Results: No visible foreign matter was detected among the 20 test products


    The standard stipulates: Among the 20 test products (bottles), no obvious visible foreign matter shall be detected (the smoke-like particle column shall not be detected when rotating, and the metal shavings, glass shavings, and fibers with a length or maximum particle size exceeding 2mm shall not be detected.


    Conclusion: meet the regulations

    Inspection of visible foreign body of Shuanghuanglian for injection (lyophilized)

    test record

    Illumination: -3000lx

    Specification: 600mg each

    Results: After 5 test samples (bottles) were dissolved in 10ml sterile water for injection, no visible foreign matter was detected


    The standard stipulates: among the 5 test products (bottles), no obvious foreign matter shall be detected


    Insoluble particles inspection of Qingkailing injection

    test record

    Instrument model: GWJ-5 particle detector

    Method: photoresist method

    Specification: 10ml each

    Preparation of test article: Take 4 test articles, combine the contents, and place them in a sampling cup


    Pretreatment: Ultrasound for 30 seconds

    Let stand: 2 minutes

    Table 19-13 Inspection results of insoluble particles of Qingkailing injection


    Results: Each 1ml contains 85 particles with an average value of 10um and above, and 8 particles with an average value of 25um and above


    Each test container contains 850 particles of 10um and above, and 80 particles of 25um and above


    The standard stipulates: For intravenous injection with a labelled volume of less than 100ml, each test container containing particles of 10um and above must not exceed 6,000, and particles of 25um and above must not exceed 600


    Conclusion: Meet the regulations


    Inspection of insoluble particles of Shuanghuanglian for injection (lyophilized)

    test record

    Instrument model: GWJ-5 particle detector

    Method: photoresist method

    Specification: 600mg each

    Preparation of test products: Take 4 test products, add 10ml of particle inspection water to dissolve them, carefully combine the dissolved solutions, and place them in the sampling cup


    Pretreatment: Ultrasound for 30 seconds

    Let stand: 2 minutes

    Table 19-14 Inspection results of insoluble particles of Shuanghuanglian for injection (lyophilized)


    Results: Each 1ml contains 114 particles with an average value of 10um and above, and 10 particles with an average value of 25um and above


    Each test container contains 1140 particles of 10um and above, and 100 particles of 25um and above


    The standard stipulates: Sterile powder for intravenous injection, each test product container must contain no more than 6000 particles of 10um and more than 10um, and no more than 600 particles of 25um and more than 25um


    Conclusion: Meet the regulations


    Inspection of the melting time limit of Baofukang suppository

    test record

    Instrument model: RBV-4 melting time limit checker

    Test product: Take 3 test products and place them at room temperature for 1 hour

    Temperature: 37°C

    Solvent: water

    Result: All 3 test samples melted within 23 minutes

    The standard stipulates: all 3 suppositories of fatty base should melt, soften, or have no hard core when touched within 30 minutes.
    Conclusion: meet the regulations

    Related links: Softening point inspection of dog skin ointment and weight difference inspection of dog skin ointment

     

     

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