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USP Chapters 41 and 1251 on Balances

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Ensure Compliance with the Latest Recommendations

USP Chapter 41 Weighing Requirements White Paper



 

 

 

 

 

 

 

This white paper comprehensively explains the requirements of the 2019 versions of USP General Chapters <41> and <1251> and provides advice on how to put these requirements into practice. Weighing according to USP requirements will ensure that a consistently high quality of weighing results is achieved and is applicable to all pharmaceutical QC activities globally, not just those operating in the USA.

Ensure that your weighing processes are compliant with the current versions of USP General Chapters <41> and <1251>.

Download the White Paper on USP Requirements for Weighing

What is USP?

The United States Pharmacopeia (USP) is a scientific, non-governmental organization that sets the official public standards for drugs and drug products in the US. These standards include the identity, strength, quality, and purity of substances manufactured, distributed, and consumed in the US. The USP drug standards are used in more than 140 countries and are enforceable in the US by the Food and Drug Administration (FDA). It has a similar legal status to the European Pharmacopoeia compendium in Europe.

 

What are USP Chapters 41 and 1251 about?

  • USP General Chapter 41 "Balances” is mandatory and states the requirements for balances used for materials that must be accurately weighed. Weighing should be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy.
  • USP General Chapter 1251 "Weighing on an Analytical Balance" is a guideline applicable to balances used in all analytical procedures. It provides information on installation and operational qualification (IQ/OQ), performance qualification and balance checks (routine testing), minimum weight, and balance operation. See the webinar on Calibration and Qualification of Laboratory Instruments.
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