Question

What are the limitations of content uniformity test?

Is this test applicable for various dosage forms, and when is it applicable?
Apr 20, 2012

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All Answers (17)

  • Ramesh Mapari · Sai Advantium Pharma Ltd.
    You have to check USP or BP general chapters for This test.
    Also refer attached ppt
    CU.pdf
    Apr 20, 2012
  • Deleted
    Ya, u have to look into usp and bp.
    Apr 20, 2012
  • Rodrigo Pérez · National Autonomous University of Mexico
    May i ask about the drug your trying to test?
    Apr 20, 2012
  • Deleted
    Than you for inviting me to comment, but this is not my area of expertice.
    Cordially
    Eugenio
    Apr 20, 2012
  • Mohammed Al-Muhur · Umm Al-Qura University
    The provided presentation was nice, as it contains the essential calculations. But you need to specify acceptance limits, these can be affected by tablet weight and drug.

    Second, the limitations of these tests are alpha and beta errors, and instrumental and human errors .
    Apr 20, 2012
  • Myrna Dolovich · McMaster University
    I believe the limits are +/- 15%.
    Apr 20, 2012
  • Gelgel Wirasuta · Udayana University
    It should be referred to validation test.
    Apr 21, 2012
  • Deepak Chourasiya · Central India Institute of Pharmacy
    First check usp and bp. According to usp content unifromity limits are <25mg or <25% for uncoated andcoated tablets.
    Apr 21, 2012
  • Dragan Milenović · Actavis, Inc.
    You have to check USP, BP or PhEur general chapters for This test.
    I reccomend PhEur, chapter 2.9.40. If you do not have it send an e-mail and I will send file.
    Apr 21, 2012
  • Kamal Tripathi · Dr. Harisingh Gour University
    Thanks a lot... For your valuable suggestions.
    Apr 21, 2012
  • Rakesh Dash · Sinhgad Technical Education Society
    The AV (acc. Value) for CU must be below 15 and all value must be within +/- 10% ( i.e. 90 to 110%). This can also vary with the monograph but the AV must be below 15.
    Apr 21, 2012
  • Waseem Kaialy · University of Kent
    It depends of pharmaceutical dosage form, drug type, and drug dose
    Apr 21, 2012
  • Gaurav Mehrotra · Gautam Buddh Technical University
    content Uniformity is a pharmaceutical analysis technique for the quality control of hard shell gelatin capsules, or tablets. It is carried out as follows:

    10 tablets at random.
    the limit is 85% to 115 % of the average content and none is outside the limits of 75 to 125 % of the average content. . According to INDIAN PHARMACOPOIEA Content of active ingredients. Determine the amount of active ingredient(s) by the method described in the Assay and calculate the amount of active ingredient(s) in each tablet. The result lies within the range for the content of active ingredient(s) stated in the monograph. This range is based on the requirement that 20tablet, or such other number as may be indicated in the monograph, are used in the Assay. .
    Apr 21, 2012
  • Waseem Kaialy · University of Kent
    90-110% in Industial guidlines, usually.
    Apr 21, 2012
  • Umang Joshi · R. K. College of Pharmacy (GTU)
    Limitations:
    The preparation complies if not more than one (all within limits) individual content is outside the limits of 85 to 115 % of the average content and none is outside the limits of 75 to 125 % of the average content.

    The preparation fails to comply with the test if more than 3 individual contents are outside the limits of 85 to 115 % of the average content or if one or more individual contents are outside the limits of 75 % to 125 % of the average content.

    This range is based on the requirement that 20 capsules, or such other number as may be indicated in the monograph, are used in the Assay. Where 20 capsules cannot be obtained, a smaller number, which must not be less than 5, may be used, but to allow for sampling errors the tolerances are widened.

    The requirements of Table 1 apply when the stated limits are between 90 and 110 per cent. For limits other than 90 to 110 per cent, proportionately smaller or larger allowances should be made Weigh of Active Subtract Weigh of Active ingredients in each Capsules. The table is given in IP.
    Apr 23, 2012
  • Haroon Rahim · Sarhad University of Science & IT
    For each and every dosage forms the limitations are given in Pharmacopoeis. Content uniformity specifications can be consulted from books like USP, BP, Eu. PH, Martindale (Extra Pharmacopoeia) etc
    Apr 23, 2012
  • Sandeep Jain · VNS Group of Institutions
    It is only applicable to tablet that contain less than 10mg or less than 10%w/w of the active ingrediant. It is not applicable to tablet containing multivitamin or trace elements
    May 3, 2012

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