Whitepaper/App Note

Whitepaper: Perform conductivity measurements in compliance with USP <645>

Posted: 13 December 2017 | | No comments yet

“Water is the most widely used substance, raw material, or ingredient in the production, processing and formulation of compendial articles…”

Chapter 1231 of the United States Pharmacopeia (USP) begins with these words in the article “Water for pharmaceutical purposes.”

In 1996, the USP developed a new method, proposed by the Water Quality Committee of the US PhRMA, in order to control and measure the quality of the water used for all pharmaceutical products wishing to enter the US market, regardless of where they are produced. This method, USP <645>, defines the suitability of Purified Water (PW) and Water for Injection (WFI) samples through conductivity readings. The raw materials used during the manufacture of pharmaceutical products have a strong impact on the quality of the final product. For this and safety reasons, all products, testing labs or quality control for pharmaceutical industry must comply with the USP requirements.

This article provides a detailed description of the USP <645> requirements, and a guidance on the instrumentation specifications and usage, along with tips and tricks on how to meet with the norm’s specifications in a clear, easy and defined way.

 

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