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    USP Chapter 41 2015

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    Anonymous cZ0Sn4hxF
    1) The new version of USP Chapter 41 focuses on defining the operating range of balances rather than minimum sample weights. It specifies requirements for repeatability and accuracy testing. 2) For repeatability, it uses 2 standard deviations rather than 3 and requires the result to be less than or equal to 0.10% rather than 0.149%. It also sets the minimum starting point of the operating range at 820 digits rather than 1000 digits. 3) For accuracy, it requires the measured weight to be within 0.10% of the test weight and for the test weight uncertainty to be 1/3 of 0.10%, with the test weight between 5-100% of the balance's capacity.

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    USP Chapter 41 2015

    Uploaded by

    Anonymous cZ0Sn4hxF
    159 views14 pages
    1) The new version of USP Chapter 41 focuses on defining the operating range of balances rather than minimum sample weights. It specifies requirements for repeatability and accuracy testing. 2) For repeatability, it uses 2 standard deviations rather than 3 and requires the result to be less than or equal to 0.10% rather than 0.149%. It also sets the minimum starting point of the operating range at 820 digits rather than 1000 digits. 3) For accuracy, it requires the measured weight to be within 0.10% of the test weight and for the test weight uncertainty to be 1/3 of 0.10%, with the test weight between 5-100% of the balance's capacity.

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    1) The new version of USP Chapter 41 focuses on defining the operating range of balances rather than minimum sample weights. It specifies requirements for repeatability and accuracy testing. 2) For repeatability, it uses 2 standard deviations rather than 3 and requires the result to be less than or equal to 0.10% rather than 0.149%. It also sets the minimum starting point of the operating range at 820 digits rather than 1000 digits. 3) For accuracy, it requires the measured weight to be within 0.10% of the test weight and for the test weight uncertainty to be 1/3 of 0.10%, with the test weight between 5-100% of the balance's capacity.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    159 views14 pages

    USP Chapter 41 2015

    Uploaded by

    Anonymous cZ0Sn4hxF
    1) The new version of USP Chapter 41 focuses on defining the operating range of balances rather than minimum sample weights. It specifies requirements for repeatability and accuracy testing. 2) For repeatability, it uses 2 standard deviations rather than 3 and requires the result to be less than or equal to 0.10% rather than 0.149%. It also sets the minimum starting point of the operating range at 820 digits rather than 1000 digits. 3) For accuracy, it requires the measured weight to be within 0.10% of the test weight and for the test weight uncertainty to be 1/3 of 0.10%, with the test weight between 5-100% of the balance's capacity.

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    The key takeaways are that the new USP Chapter 41 focuses on defining the operating range of balances through determining the starting point based on repeatability tests and accuracy specifications, rather than minimum sample weight. It also lowers the tolerance for measurement uncertainty from 0.1% to 0.10%.

    The main changes in the new USP Chapter 41 compared to the old version are that the scope applies to all sample weights rather than just assays, it determines the operating range rather than minimum sample weight, lowers the repeatability tolerance from 0.1(49)% to 0.10%, changes the acceptance criterion and lowest starting point/sample weight definitions.

    Repeatability according to the new USP Chapter 41 refers to calculating the starting point of the operating range through 10 repeat measurements and determining if the standard deviation is within 2 times the nominal value or 0.10%.

    United States Pharmacopeia – Chapter 41 New Release

    Dirk Ahlbrecht
    Director Marketing Lab Weighing • Sartorius LPS
    UPS Expert Panel Member for USP Chapters 41 and 1251
    May, 2015
    Have you heard about
    the new USP?

    ...it’s easier than you think!


    US Pharmacopeia Chapter 41 “Balances” – it’s easier than you think!

    ... it’s all about accurate measurements!

    • A balance always has a measuring uncertainty error


    • The smaller the sample, the larger the effect of the measuring uncertainty error (relatively)
    • USP dictates a maximum uncertainty error of 0.10%
    • This demand specifies the usable weighing range (operating range) of the balance

    measuring
    uncertainty
    error (rel.)
    1% Operating Range
    not allowed

    0.10%

    sample
    weight
    0%
    0g 1g 10g 100g 200g max
    X mg
    capacity
    US Pharmacopeia Chapter 41 “Balances” – Background

    • FDA inspects customers on USP regulations

    • USP Chapter 41 is mandatory

    • Minimum accuracy of 0.10% for important


    measurements is dictated

    Please note:
    • Near its zero point, a balance is relatively inaccurate.
    • The higher you go in a balance’s weighing range, the
    more accurate it is (relatively)
    US Pharmacopeia Chapter 41 “Balances” – New Release

    • From December 1st 2013 on, the new USP release has
    been available
    • From July 1st 2014 the first revision of Chapter 41 is
    active

    • First significant changes of Chapters 41 and 1251


    after 20 years

    • e.g. renamed from Weights and Balances to Balances

    • It does not reference minimum sample weight


    anymore, it defines Repeatability and Accuracy, which
    specifies the Operating Range
    US Pharmacopeia Chapter 41 “Balances” – New Release

    1. Repeatability:
    • Defines the starting point of the operating
    range of the balance

    • Calculation from 10 measurements

    2 SD
     0.10% • 2 x Standard Deviation / nominal value ≤
    W 0.10 %

    OR min  2 * SD * 1000 • The starting point of the operational


    weighing range

    • When SD < 0.41d, it must be replaced by


    OR min  2 * 0 .41 * 1000  820 d 0.41 digits

    OR = Operating Range
    SD = Standard Deviation
    d = Digit
    W = smallest desired Net Weight
    US Pharmacopeia Chapter 41 “Balances” – Repeatability

    What does this mean?

    1. The new USP does not refer to minimum sample weight anymore. It specifies the operating
    range. The operating range is specified by the capacity and a “starting point” (formally known as
    minimum sample weight) – so this starting point needs to be defined according to the
    Repeatability determination routine.

    weight on
    balance max capacity, e.g. 220 g
    starting point
    200 g
    with min accuracy of
    0.10%
    Please note:

    100 g The higher you get in the


    weighing range of a
    balance, the more
    accurate (%) it is!

    0g 100 g 200 g displayed weight value


    US Pharmacopeia Chapter 41 “Balances” – Repeatability

    What does this mean?

    2. The determination parameters are modified:

    old: 3 x SD (three times standard deviation)


    new: 2 x SD (two times standard deviation) - 30%

    old: 0.1 % (which means 0.149%)


    new: 0.10% (not possible to enlarge) + 30 %

    • So the result will be in a similar range


    • No significant changes expected!
    US Pharmacopeia Chapter 41 “Balances” – Repeatability

    What does this mean?


    Please note:
    3. The absolute minimum is defined new d = digit
    A digit is one displayed
    old: 1000 d (acc. Sartorius interpretation) step on a balance
    new: 820 d (2 x 0.41d x 1000 = 2 x 410d)

    • This means that the maximum operating range for a Sartorius balance goes from
    820d to max capacity:

    Operating Range
    Balance Type Readability
    optimal typical*
    MS*2.7S 0.1 µg 0.082 mg – 2 g 1 mg
    MS*6.6S 1 µg 0.82 mg – 6 g 1- 2 mg
    MS*225S 0.01 mg 8.2 mg – 220 g 20 mg
    MS*224S 0.1 mg 82 mg – 220 g 90 mg
    MS*623S 1 mg 820 mg – 620 g 900 mg

    *based on Sartorius’ experience


    US Pharmacopeia Chapter 41 “Balances” – Accuracy

    2. Accuracy:

    • Defines the test weight and the weight class

    • Weight must be within 5% to 100% of

    Vm  0.10%Wt capacity
    • Deviation of measured value compared to
    weight value ≤ 0.10% of weight value

    Mw  1 / 3 * 0 .10 % • The measuring uncertainty of the weight must


    be 1/3 of 0.10%

    Wt = Test Weight
    Mw= measuring uncertainty of weight
    Vm = Wt ± Mw
    US Pharmacopeia Chapter 41 “Balances” – Accuracy

    What does this mean?

    1. The USP describes the quality of the weights, used for this test

    e.g. 100 g Accuracy ≤ 0.1 g 99.9000 ... 100.1000 g


    Measuring uncertainty ≤ 0.03 g

    • Customers must use calibrated weights to be able to show the uncertainty of the
    weights – an extra service we can provide!

    • No need to use higher class weights, ASTM Class 2 traceable weight (OIML F1 or F2)
    with certificate is often absolutely enough!
    US Pharmacopeia Chapter 41 “Balances” – New Release

    Additional Information:

    • The USP now defines that customers must use “calibrated balances”
    • There are different ways to calibrate a balance
    • A well accepted method is according to ISO 17025
    US Pharmacopeia Chapter 41 “Balances” – Summary

    Chapter 41 Old New


    Applies only to assays of substances Applies to all sample weights
    Scope of validity Determination of the minimum sample
    Determination of the operating range
    weight

    Repeatability (around the starting point)

    Repeatability tolerance 0.1(49)% 0.10%

    Expansion factor K 3 2

    Number of weighing values for the repeatability


    10 10
    test

    Acceptance criterion 3 x std. dev./m ≤ 0.1% 2 x std. dev./m ≤ 0.10%

    Smallest possible sample weight/lowest starting


    1,000 d 820 d
    point

    Accuracy

    Tolerance None specified ≤ 0.10%

    Between 5% and 100% of the


    Test weight None specified
    balance’s capacity
    Thank you very much for
    your kind attention

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