Be Compliant with European Pharmacopoeia Chapter 2.1.7

European Pharmacopoeia Chapter 2.1.7 

On January 1st, 2022, the new Chapter 2.1.7, published by the European Pharmacopoeia (Ph.Eur.) and pertaining to balances used for analytical purposes, became effective. One of the highlighted features describes requirements for checking instruments between calibrations (during routine use). Performance checks include verification of repeatability and sensitivity, two critical parameters for ensuring proper functioning of analytical balances.

The Ph.Eur. is the legally binding reference for all companies placing pharmaceutical products in European member states. As such, the new chapter applies to any producers of medicines and/or substances for pharmaceutical use exported into the European market, regardless of location.

Please check our FAQs about Chapter 2.1.7 and learn how you can ensure adherence to the updated European Pharmacopoeia guidelines. Be sure to download the full set of FAQs for an in-depth discussion of Chapter 2.1.7.

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Are there any specific requirements to make a balance model compliant with Chapter 2.1.7 of the European Pharmacopoeia?

Nothing makes a particular balance model compliant or non-compliant with Chapter 2.1.7 of the European Pharmacopoeia. However, there are some general requirements listed in Chapter 2.1.7, such as it must be ensured “the installation and operating conditions do not have a negative impact on the performance of the balance.”

The only specific requirement is the balance must be grounded, which is usually the case (via electrical supply) for state-of-the-art models.

What is the meaning of “analytical purposes?” Are preparational weighings (e.g. preparing buffer solutions) also subject to regulation?

Chapter 2.1.7 specifies that “Any weighings performed as part of tests prescribed to establish compliance with a monograph of the Ph.Eur. must be carried out according to the principles outlined in this chapter.” When determining whether a balance is affected, users should consider this statement. If in doubt, they should consider whether the result of the weighing is relevant for the assessment of compliance with the corresponding monograph. It should also be noted that the preparation of a buffer solution can be affected by the new chapter of the European Pharmacopoeia.

How does the Cubis® II support compliance with Chapter 2.1.7 of the Ph.Eur.?

The Pharma Software package available for Cubis® II lab balances helps customers successfully meet requirements set by both the new Ph.Eur. chapter 2.1.7 and the USP, chapter 41.

Our USP Advanced QApp is used to check the performance of balances and offers a guided workflow to determine minimum sample weight acc. to USP Chapter 41 or the new Ph.Eur. Chapter 2.1.7. Our Minimum Weight application monitors weight determined by the USP Advanced QApp and checks it against permitted ranges as per different guidelines. These applications can be paired with add-on advanced software programs for determining and monitoring the measurement uncertainty. 

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Frequently Asked Questions

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Nothing makes a particular balance model compliant or non-compliant with Chapter 2.1.7 of the Ph.Eur. However, there are some general requirements listed in Chapter 2.1.7, such as it must be ensured “the installation and operating conditions do not have a negative impact on the performance of the balance.”

The only specific requirement is the balance must be grounded, which is usually the case (via electrical supply) for state-of-the-art models.
 

Chapter 2.1.7 specifies that “Any weighings performed as part of tests prescribed to establish compliance with a monograph of the Ph.Eur. must be carried out according to the principles outlined in this chapter.” When determining whether a balance is affected, users should consider this statement. If in doubt, they should consider whether the result of the weighing is relevant for the assessment of compliance with the corresponding monograph. It should also be noted that the preparation of a buffer solution can be affected by the new chapter of the European Pharmacopoeia.
 

During calibration, a relationship is established between the known value of test weights and the associated indicated value of the balance. Chapter 2.1.7 states “… instruments must be periodically calibrated …by the user or by a suitable competent body.”

There are three requirements stipulated in Chapter 2.1.7 of the Ph.Eur.:

  • Calibration must establish traceability of measurement results to the SI units.
  • Calibration results must include an associated measurement uncertainty.
  • It is recommended to perform an “as found” calibration before any maintenance operation that significantly alters measurements and to perform a second calibration (“as left”) afterwards. 

Significant operations according to Chapter 2.1.7 include repairs, transfer of the balance to another location or mechanical adjustments.

We recommend having calibrations conducted by an accredited calibration laboratory, as in this case, competence is ensured through the accreditation and the above requirements are fulfilled.
 

The Pharma Software package available for Cubis® II lab balances helps customers successfully meet requirements set by both the new Ph.Eur. chapter 2.1.7 and the USP, chapter 41.

Our USP Advanced QApp is used to check the performance of balances and offers a guided workflow to determine minimum sample weight acc. to USP Chapter 41 or the new Ph.Eur. Chapter 2.1.7. Our Minimum Weight application monitors weight determined by the USP Advanced QApp and checks it against permitted ranges as per different guidelines. These applications can be paired with add-on advanced software programs for determining and monitoring the measurement uncertainty. 

  • In the applicability of the respective chapter, the Ph.Eur. (“analytical purposes”) is somewhat broader than the USP (“substances that must be weighed precisely”).
  • The Ph.Eur. explicitly requires the traceability of measurement results to the SI unit.
  • The Ph.Eur. explicitly states calibration of the balance must include a measurement uncertainty calculation.
  • For the repeatability check, the Ph.Eur. requires a test load no bigger than 5% of the maximum capacity of the balance but at least 100 mg. The USP does not give any comparable restrictions.
  • The “sensitivity” check of the Ph.Eur. is similar to the “accuracy” check of the USP, but the acceptable deviation of 0.05% in the Ph.Eur. is smaller than 0.10% in the USP.
  • For both performance checks, the Ph.Eur. explicitly requires single-piece test loads, while this is not the case in the USP.

For the repeatability check, a single-piece test load - no bigger than 5% of the maximum capacity of the balance but at least 100 mg – is used. This weight is placed at least 10 times on the weighing pan. Before each measurement, the balance is set to zero. Repeatability is satisfactory if two times the standard deviation of measured values divided by smallest net weight defined by the user is no greater than 0.10%. In cases where standard deviation (s) is smaller than 0.41 × d (where d is the actual scale interval of the balance), s is replaced by 0.41 × d.

For the sensitivity check, a single-piece test load with a weight between 5% and 100% of the capacity of the balance is placed on the balance. Sensitivity is satisfactory if the difference between the indicated value of the balance and the nominal weight of the test load (or its conventional mass, see Question #15 in the FAQs) is no more than 0.05%.

The smallest possible sample weight on a balance, or minimum sample weight (mmin), is 2000 times the standard deviation of the repeatability measurement. Thus, if the standard deviation s is, for example, s = 0.00015 g, the smallest possible sample weight is mmin = 0.3000 g = 300 mg.

The additional requirement of replacing the determined standard deviation with 0.41 × d in cases where the standard deviation is less than 0.41 × d (where d is the actual scale interval of the balance), sets the smallest possible sample weight that can be weighed on a balance at 820 × d. For a four-digit analytical balance with d = 0.0001 g, for example, this means that the smallest possible minimum sample weight can never be less than 0.0820 g or 82 mg.

Resources

Laboratory Balances in the Pharmaceutical Industry

Pharmaceutical regulations – including rules for testing and analyzing drugs – must be met when pharma companies want to put their manufactured products on the market.  These regulations are outlined in pharmacopeias – e.g. the United States Pharmacopeia (USP) for the US market and the European Pharmacopoeia (Ph.Eur.) for the European market.

While the US Pharmacopeia has featured a chapter on the use of laboratory balances for several years, a respective chapter has only recently been introduced to the Ph.Eur. It became mandatory in January 2022.

This graphic summarizes lab balance regulations according to both pharmacopeias - and highlights the differences between them.

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Use of Laboratory Balances in the Pharmaceutical Industry - White Paper

On July 1, 2021, the new European Pharmacopoeia (Ph.Eur.) Chapter 2.1.7 "Balances for Analytical Purposes" will be published and, after a transition period of six months, become mandatory on January 1, 2022 for pharmaceutical companies manufacturing or exporting into the European market.

The new chapter describes principles for the use of balances used in analytical procedures including calibration and performance checks to maintain performance.

Our new white paper summarizes the concepts of the well-known USP Chapters <41> and <1251> and the new European Pharmacopoeia (Ph.Eur.) Chapter 2.1.7.

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Pharmacopoeia Compliance Guide: Chapter 2.1.7 Ph.Eur. "Balances for analytical purposes”

The new chapter 2.1.7 “Balances for analytical purposes” of the European Pharmacopoeia (Ph.Eur.) was published in July of 2021 and became effective January 1, 2022. The Ph.Eur. is the legally binding reference for all pharmaceutical companies placing pharmaceutical products in the market of European member states.

Download our FAQ guide to learn how to ensure adherence to the updated European Pharmacopoeia guidelines as well as how our Cubis® II laboratory balance supports this.

Download Compliance Guide

Pharmacopoeia Compliance Guide: Kapitel 2.1.7 Ph.Eur. "Waagen für analytische Zwecke"

Das neue Kapitel 2.1.7 "Waagen für analytische Zwecke” der Europäischen Pharmakopöe (Ph.Eur.) wurde im Juli 2021 veröffentlicht und trat am 1. Januar 2022 in Kraft. Die Ph.Eur. ist für alle pharmazeutischen Unternehmen, die Arzneimittel in den europäischen Mitgliedsstaaten auf den Markt bringen, rechtsverbindlich. 

Unser FAQ Leitfaden erklärt wie Konformität mit den aktualisierten Europäischen Pharmakopöe Richtlinien eingehalten werden kann und wie unsere Cubis® II Laborwaage dabei unterstützt.

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