Pharmacopeia Compliance: Balancing Standards Across Global Markets

Oct 21, 2024
By Dr. Julian Haller, Scientist | Engineer Metrology at Sartorius Lab Instruments GmbH & Co. KG

Pharmacopeias are crucial for maintaining uniformity and controlling medicine standards in the pharmaceutical industry. However, the numerous and sometimes conflicting requirements across different markets pose a compliance challenge due to a lack of harmonization. Some of these requirements, particularly those mentioned below, apply to balances used in QC labs, where the "minimum weight" (the smallest amount that may be weighed while staying compliant with the requirements) is especially relevant.

The United States Pharmacopeia (USP) has, for several years, included two chapters detailing balance requirements: one mandatory (chapter <41>) and one recommended (chapter <1251>).

In 2021, the European Pharmacopoeia (Ph. Eur.) introduced chapter 2.1.7, addressing balance requirements.

And recently, the Japanese Pharmacopeia (JP) revised chapter 9.62, which previously only classified different types of balances, to include explicit requirements on balances and weights. Additionally, they added three new chapters (<G1-6-182>, <G1-7-182>, and <G1-8-182>) to the "General Information" section.

Sartorius offers several resources to assist balance users in understanding requirements and documenting test results properly:

Additionally, Sartorius staff are actively involved in ongoing revisions of the relevant chapters in USP and Ph. Eur. to ensure that balance users receive timely and relevant information.

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