croatia The New United States Pharmacopeia (USP) Chapter 41 It s easier than you think!

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1 croatia The New United States Pharmacopeia (USP) Chapter 41 It s easier than you think!

The new USP Chapter 41 Area of Application Chapter 41 will solely apply to balances and not to weights anymore. So far, the USP Chapter 41 was named Weights and Balances.

2 The new USP Chapter 41 Area of Application Chapter 41 will solely apply to balances and not to weights anymore. So far, the USP Chapter 41 was named Weights and Balances. With its new release in December 2013 the name will change to Balances only, which indicates its major scope. Likewise, Chapter 41 does not refer to minimum sample weights any longer. Instead, it newly defines the terms Repeatability and Accuracy. Both concepts are of crucial importance as they together define the Operating Range of a balance. Recommendation If you follow our recommendations on how to perform the repeatability and accuracy testing, you will be compliant with the new requirements of Chapter 41 it s really that easy!

3 Repeatability According to the new USP Chapter 41 repeatability defines the starting point of a balance s operating range. How to calculate it? Perform 10 measurements with the exact same weight Calculate 2 x Standard Deviation (SD) / nominal value 0.10 % Calculate the starting point of the Operating Range: 2 x SD x 1000 If SD < 0.41 digits, replace it by 0.41 digits. What does this mean? The higher you go in a balance s weighing range, the more accurate it is, relatively. Your results will be in a similar range as with the old determination parameters, so you should not expect any significant changes.

4 Accuracy Chapter 41 defines the process requirements to check the accuracy of a balance. In order to test a balance s accuracy, Chapter 41 requires you to use a test weight which has a mass of 5 % to 100 % of the balance s maximum capacity. How to calculate it? The measurement uncertainty of the weight must be 1/3 of 0.10 % Take one measurement with a mass of 5 % to 100 % of the balance s capacity The deviation of the measured value should be 0.10 % of the weight value What does this mean? The USP describes the quality of the weights to be used for this test. This means you must use a calibrated weight to prove the uncertainty of that weight. However, you do not need to use higher class weights. OIML Class F1 or F2 weights are usually sufficient.

5 USP Chapter 1251 The USP Chapter on Weighing on an Analytical Balance is not mandatory! The most important piece of information on the USP Chapter 1251 on Weighing on an Analytical Balance is that it is only a recommendation you are not required to follow the procedures described in this chapter. Chapter 1251 describes: Balance qualification Balance calibration Risk analysis (risk-based approach)

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The New Practum. Unmatched reliability with the world-class weighing instrument

The New Practum. Unmatched reliability with the world-class weighing instrument The New Practum Start Weighing Right. Unmatched reliability with the world-class weighing instrument Laboratory Balances Made in Germany Overload protection for years of reliability Supervisor Lock Fast