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Use of Laboratory Balances in the Pharmaceutical Industry – USP <41>, <1251> & Ph. Eur. 2.1.7

Use of Laboratory Balances in the Pharmaceutical Industry – USP <41>, <1251> & Ph. Eur. 2.1.7

 

Use of Laboratory Balances in the Pharmaceutical Industry – USP

From USP <41> to Ph. Eur. 2.1.7—precision begins with the right balance.

Pharmaceutical manufacturing depends on data integrity at every step—starting with weighing. This essential white paper from Sartorius provides a comprehensive comparison of key regulatory frameworks—USP <41>, USP <1251>, and Ph. Eur. 2.1.7—outlining the exact balance performance requirements needed for GxP compliance and audit readiness.

What you’ll learn:

  • Minimum sample weight guidelines for accurate weighing in line with USP and European Pharmacopoeia standards.
  • Repeatability and sensitivity testing protocols to maintain traceability and reduce analytical risk.
  • The role of calibration and how ISO/IEC 17025-accredited services ensure global recognition and metrological traceability.
  • Differences between formal and informal chapters (USP <41> is enforceable, <1251> is advisory).
  • How to comply with Ph. Eur. 2.1.7. using internal test weights and reduced external testing frequency.

Why it matters:

  • USP <41> mandates that balances used for “accurate weighing” meet strict criteria for calibration, repeatability (≤0.10% relative error), and minimum sample weight calculations.
  • Ph. Eur. 2.1.7 requires on-site performance testing and repeatability validation using small test weights (≥100 mg).
  • The chart on page 7 clarifies how to calculate and verify the minimum sample weight using 2 × σ / m ≤ 0.1%.
  • Sartorius offers dedicated certificates to document compliance with all major standards, aiding in audits and SOP documentation.

Regulatory ready. Statistically sound. Proven at scale.

Whether you’re preparing for a GMP audit or standardising your lab’s weighing practices, this guide gives you the clarity and tools to define weighing protocols that meet global pharmaceutical standards.

Download the white paper and get your weighing workflows fully aligned with USP and Ph. Eur. compliance today.

White Paper from  Sartorius_Logo Brought to you by: analytical_logo

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