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  • 1.  numNumber of tablet/capsule unit for sample preparation in the Assay testing

    Posted 18-Dec-2015 10:35

    Dear All, 

    Does anyone have experience that some Health Authorities require minimum number of tablet/capsule unit for sample preparation in the Assay testing (eg >=10). 

    Thanks, 

    Qianwei

    ------------------------------
    Qianwei Han RAC
    Senior Associate, Regulatory Affairs
    Johnson and Johnson
    Pennington NJ
    United States
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  • 2.  RE: numNumber of tablet/capsule unit for sample preparation in the Assay testing

    Posted 20-Dec-2015 13:07

    Hi,

    Per USP, a minimum of 10 units are required for assay testing.

    Thanks,

    Bhaskar

    ------------------------------
    Bhaskar Banala
    Cary NC
    United States

    Original Message


  • 3.  RE: numNumber of tablet/capsule unit for sample preparation in the Assay testing

    Posted 21-Dec-2015 15:49

    Dear Bhaskar, 

    Thank you for your reply. Could you please be more specific which USP specifies the minimum 10 units for sample solution preparation as a general requirement? I am talking about assay method, not uniformity of dosage unit / content uniformity test method. 

    KR, 

    Qianwei


    Original Message


  • 4.  RE: numNumber of tablet/capsule unit for sample preparation in the Assay testing

    Posted 21-Dec-2015 08:25

    Just keep in mind that "Assay" and "Uniformity of Dosage Units" (of which "Content Uniformity" is a subset) are separate requirements in the USP. According to the USP (General Notices 5.70 Performance Tests), where content uniformity determinations have been made using the same analytical methodology specified in the Assay, the average of all the individual content uniformity determinations may be used as the Assay value.  Content Uniformity may require the use of an additional 20 units (L2), depending on the results obtained from the first 10 (L1).

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    Mark Lookabau
    Principal Consultant
    PAREXEL International, LLC
    Stafford Springs CT
    United States

    Original Message


  • 5.  RE: numNumber of tablet/capsule unit for sample preparation in the Assay testing

    Posted 21-Dec-2015 16:16
    Please refer to 905 and 34.  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 6.  RE: numNumber of tablet/capsule unit for sample preparation in the Assay testing

    Posted 22-Dec-2015 07:54

    Dear David, 

    Thank you for your information. USP 905 is about uniformity of dosage units, and 34 mentions that the test results of uniformity of dosage units can be used for assay purpose under certain conditions. However, I am looking for the general requirement of minimum number of units for sample solution preparation in API assay methods. For example, is there any guidance saying minimum 10 (or any other number) units are required for sample solution preparation in assay method?  

    Thanks, 

    Qianwei


    Original Message


  • 7.  RE: numNumber of tablet/capsule unit for sample preparation in the Assay testing

    Posted 22-Dec-2015 16:28
    Qianwei,

    "Sample preparation for API assay methods"

    It would depend on few factors: 1). what kind of a sample preparation; 2). what kind of API?; 3). for what assay methods (e.g., HPLC).

    Sometimes, you may have to ground tablets for your intended sample prep for the desired assay. Four tablets may be needed.  For some other cases, you may have to use 6 tablets to perform your desired assay. 

    To get some insight and rationale, you may refer to FDA's recent methods validation guidance. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message