What is the Scope of USP 41 and Ph. Eur. 2.1.7.?
General Chapters USP 41 and Ph. Eur. 2.1.7. cover balances used for analytical purposes in the pharmaceutical industry. Both chapters address equipment performance and introduce three measures:
- Calibration results must be documented in a calibration certificate including measurement uncertainty (this is a must)
- Performance checks/routine testing carried out between calibrations – repeatability & accuracy tests with an acceptance criterion of 0.10% (this is a must)
- Adjustment of the balance by means of built-in weights (this is a state-of-the-art practice)
Please note: These chapters and the requirements in them only apply to pharmaceutical quality control. They are not applicable for pharmaceutical manufacturing.
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