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This document provides an interim revision announcement about the requirements for balances used for accurately weighing materials. It states that balances must be calibrated over their operating range and meet requirements for repeatability and accuracy. Repeatability is satisfactory if repeating weight measurements 10 times shows a standard deviation that is less than 10% of the desired smallest net weight to be measured. Accuracy is satisfactory if a suitable test weight is weighed within 0.1% of its actual value.
This document provides an interim revision announcement about the requirements for balances used for accurately weighing materials. It states that balances must be calibrated over their operating range and meet requirements for repeatability and accuracy. Repeatability is satisfactory if repeating weight measurements 10 times shows a standard deviation that is less than 10% of the desired smallest net weight to be measured. Accuracy is satisfactory if a suitable test weight is weighed within 0.1% of its actual value.
This document provides an interim revision announcement about the requirements for balances used for accurately weighing materials. It states that balances must be calibrated over their operating range and meet requirements for repeatability and accuracy. Repeatability is satisfactory if repeating weight measurements 10 times shows a standard deviation that is less than 10% of the desired smallest net weight to be measured. Accuracy is satisfactory if a suitable test weight is weighed within 0.1% of its actual value.
brated. Because the standard deviation (IRA 1-Jul-2014) is virtu-
41 BALANCES ally independent of sample mass within the balances ca- pacity, use of a small test weight, which may be difficult to handle, is not required.] This chapter states the requirements for balances used for Repeatability is satisfactory if two times the standard materials that must be accurately weighed (see General No- deviation of the weighed value, divided by the desired tices, 8.20). Unless otherwise specified, when substances smallest net weight (i.e., smallest net weight that the users must be accurately weighed, the weighing shall be per- plan to use on that balance), (IRA 1-Jul-2014) does not exceed formed using a balance that is calibrated over the operat- 0.10%. If the standard deviation obtained is less than ing range and meets the requirements defined for 0.41d, where d is the scale interval, replace this standard repeatability and accuracy. For balances used for other ap- deviation with 0.41d. In this case, repeatability is satisfac- plications, the balance repeatability and accuracy should be tory if 2 0.41d, divided by the desired smallest net commensurate with the requirements for its use. weight, (IRA 1-Jul-2014) does not exceed 0.10%. For a discussion of the theoretical basis of these require- ments, see general information chapter Weighing on an An- ACCURACY alytical Balance 1251, which may be a helpfulbut not mandatoryresource. The accuracy of a balance is satisfactory if its weighing value, when tested with a suitable weight(s), is within Change to read: 0.10% of the test weight value. A test weight is suitable if it has a mass between 5% and 100% of the balances capacity. The test weights maxi- mum permissible error (mpe), or alternatively its calibration REPEATABILITY uncertainty, shall be NMT one-third of the applied test limit of the accuracy test. [NOTEApplicable standards are the Repeatability is assessed by weighing one test weight following: ASTM E617 (available from http://www.astm. NLT 10 times. [NOTEThe test weight must be within the org) and OIML R 111 (available from http://www.oiml. balances operating range, but the weight need not be cali- org).]
2014 The United States Pharmacopeial Convention All Rights Reserved.
Milan B. Arambašić:
Calculation of bacterial endotoxin limit concentration in injectable products: DIKLOFEN® (diclofenac sodium) and NOVALGETOL® (metamzole sodium) inj.
6rd World Meeting on Pharmaceutics, Biopharmaceutics and
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10.4.2008.