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    asian journal of pharmaceutical sciences 11 (2016) 40–41

    H O S T E D BY
    Available online at www.sciencedirect.com

    ScienceDirect

    j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / a j p s

    Original Research Paper

    IP4

    Establishing acceptance limits for uniformity of


    dosage units

    Pramote Cholayudth *
    Biolab and PM Consult, Samutprakarn 10540, Thailand

    A R T I C L E I N F O

    Article history:
    Available online 23 November 2015

    Keywords:
    Uniformity of dosage units
    Acceptance value
    Acceptance limit
    Acceptance value (AV) distribution

    Uniformity of dosage units [1] is one of the most commonly Since AV is a kind of sample statistics, sampling distribu-
    employed compendial tests to evaluate the dosage units. In tion of the AV data can be plotted as AV distribution (Fig. 1).
    the test, the acceptance value (AV) is the key statistics-based To develop the AV probability density function (pdf) formula
    acceptance parameter with the limit of not more than 15 to is to derive from McKay’s coefficient of variation (CV) distri-
    measure the uniformity degree of the dosage units in terms bution equation [6]. To confirm the validity of the formula is
    of content uniformity or weight variation as applicable. With to conduct a computer simulation using MS Excel program.
    quality assurance (QA) principle, there should be some Fig. 1 also illustrates the successful simulation test result. One
    kinds of predetermined acceptance limits, like Bergum of the key benefits of the constructed AV distribution is to es-
    method introduced by James S. Bergum in 1990 [2] and 2007 tablish the predetermined acceptance limit for AV results, say
    [3] and recently recognized by ASTM 2709 [4] and ASTM 2810 the percentage point at 99% of the distribution (i.e. AV NMT
    [5] to ensure that the AV results for any future quality 12), rather than directly using the compendial limit. For vali-
    control (QC) samples will not exceed the compendial limit dation data (samples greater than QC samples), validation
    (NMT 15). acceptance criteria can be established as well.

    * E-mail address: cpramote2000@yahoo.com.


    Peer review under responsibility of Shenyang Pharmaceutical University.
    http://dx.doi.org/10.1016/j.ajps.2015.10.027
    1818-0876/© 2016 Production and hosting by Elsevier B.V. on behalf of Shenyang Pharmaceutical University. This is an open access
    article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
    asian journal of pharmaceutical sciences 11 (2016) 40–41 41

    5.0%
    Acceptance Value Distribution (Simulation Test)

    4.5% Simulated AV Distribution (n = 10, k =


    90000, N = 900000): AV Average = 7.05,
    4.0% Max = 14.1, Min = 1.49, SD = 1.66, k
    Value = 2.4, Lot CpK = 1.67
    3.5%
    Theoretical AV Distribution (n = 10, k
    Value = 2.4): Mean = 7.13, SD = 1.67
    3.0%
    Frequency

    2.5%

    2.0%

    1.5%

    1.0%

    0.5%

    0.0%
    40

    20

    00

    80

    60

    40

    20

    00

    80

    60

    40

    0
    .2

    .0

    .8

    .6

    .4

    .2

    .0

    .8

    .6
    1.

    2.

    3.

    3.

    4.

    5.

    6.

    7.

    7.

    8.

    9.

    10

    11

    11

    12

    13

    14

    15

    15

    16
    Acceptance Value (AV)

    Fig. 1 – Acceptance Value (AV) Distribution.

    REFERENCES [4] ASTM Standard. #E 2709 – 09: standard practice for


    demonstrating capability to comply with a lot
    acceptanceprocedure, September 2009.
    [5] ASTM Standard. # E2810 – 11: standard practice for
    [1] The United States Pharmacopeial Convention, Inc. <905>
    demonstrating capability to comply with the test for
    Uniformity of dosage units. 37th ed. United States
    uniformity of dosage units, October 2011.
    Pharmacopeia; 2014.
    [6] McKay A. Distribution of the coefficient of variation and
    [2] Bergum JS. Constructing acceptance limits for multiple stage
    the extended ‘T’ distribution. J R Stat Soc 1932;95:695–
    tests. Drug Dev Ind Pharm Marcel Dekker, Inc. 1990;16:2153–
    698.
    2166.
    [3] Bergum JS, Li H. Acceptance limits for the new ICH USP 29
    content-uniformity test. Pharm Technol 2007;31(10).

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