Because the calibration of balances is a mandatory requirement of USP Chapter 41, METTLER TOLEDO offers the certificate USP General Chapter 41 "Balances".
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 WeighingWhat 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.
How Can METTLER TOLEDO Support You?
Related Documents
USP Chapter 41 Weighing Requirements
This white paper explains the weighing requirements of USP Chapter 41 "Balances" and USP Chapter 1251 "Weighing on an Analytical Balance". Learn how to ensure consistently high-quality results.
Certificates USP 41 & Ph. Eur. 2.1.7
General chapters USP 41 and Ph. Eur. 2.1.7 address equipment performance and introduce three measures to be carried out periodically in laboratory weighing.
European Pharmacopoeia Chapter 2.1.7
Download a free white paper PDF to ensure that your weighing processes are compliant with Ph. Eur. Chapter 2.1.7. Ensure compliance with the latest guidelines.
USP Guidelines for Weighing in the Pharmaceutical Industry
This reference paper explains the USP Chapters 41 and 1251 on weighing and how to ensure compliance. A risk-based approach to optimize balance calibration and testing is presented.
Webinars and eLearnings
Webinar: European Pharmacopoeia "Balances for Analytical Purposes"
This webinar explains everything you need to know about the new Ph. Eur. General Chapter 2.1.7 "Balances for Analytical Purposes".
Videos