USP Requirements for Volumetric Instruments

How to Work with Different Standards in the Lab

  • Examples for inscriptions of 5 ml transfer pipet in accord with ISO (left) or USP/ASTM (right).Examples for inscriptions of 5 ml transfer pipet in accord with ISO (left) or USP/ASTM (right).

Companies producing pharmaceutical products for the US market are monitored by US authorities, e.g. the FDA (Food and Drug Administration) and have to meet the requirements of the USP (United States Pharmacopeia). Besides many instructions for analytical procedures the USP defines the equipment to be used for these processes. However, the differences between USP and DIN EN ISO can pose a difficult task for work with glass volumetric instruments in European labs.

Section 31 outlines the requirements for volumetric instruments to be utilized. A most important requirement of the USP is the mandatory use of glass volumetric instruments with accuracy according to class A. Due to some clauses this seemingly easy demand eventually turns out to be difficult to understand.

 

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