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  • 1.  Blend uniformity Vs Stratified content uniformity

    Posted 05-Apr-2017 12:01
    Hello All,

    Has anybody encountered a situation for Extended release low dose tablets where the blend uniformity does not pass but the stratified content uniformity is within the range?

    Is there anyway to justify this? I would appreciate your insight in this. 


    Thanks,
    Mehul 

    ------------------------------
    Mehul Govani RAC
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
    ------------------------------


  • 2.  RE: Blend uniformity Vs Stratified content uniformity

    Posted 05-Apr-2017 19:23
    Mostly that could happen due to sampling error of the blend uniformity with sample thief. It really matters the particle size distribution of the materials that perform the major role in the sampling.

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    Gaurang Bhavsar
    Edison NJ
    United States
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    Original Message


  • 3.  RE: Blend uniformity Vs Stratified content uniformity

    Posted 05-Apr-2017 21:37
    Hi All,

    I agree with Gaurang, most likely due to sampling.  It's a common problem for low dose blend. 
    There are many possible causes for sampling issue.  I would suggest you to look into quality sampling and analytical sampling.  
    Are you collecting the samples from blender?  Do you collect sufficient amount of samples for analytical testing?  Are you using the whole sample bottle for testing?  or you measure based on the unit target weight?  Are you using the appropriate measuring tools and analytical sampling procedure?  

    I hope you find your answer soon!

    Best Regards,

    ------------------------------
    Tyng-Yi (Tina) Lee MS RAC
    Consultant
    North Brunswick NJ
    United States of America
    ------------------------------

    Original Message


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