USP Pharmaceopeial Forum PF 55 (4)
Comment are open until 30-Sep-2025
USP has published a proposed revision in 〈1231〉 Water for Pharmaceutical Purposes. This proposal is based on the version of the chapter official as of December 1, 2021. On the basis of comments and frequently asked questions received from stakeholders, it is proposed to make the following changes:
- Add a new subsection, 7.5 Nitrosamines, to explain the low risk of having contributors (nitrosamines or their precursors) as well as the need for a control strategy and a risk-based approach, if deemed appropriate.< as part of their continuous revision process have published a proposed revision
▲7.5 Nitrosamines
The presence of nitrosamines or their precursors in Purified Water and Water for Injection is directly related to their concentration in the starting water and the effectiveness of the water purification processes. A well-designed water purification system—utilizing softener, reverse osmosis, UV lamps, ion-exchange, distillation, etc.—will generally remove nitrosamine and contributing precursor impurities (e.g., ammonium, amines, nitrates, nitrites). Although no water system can guarantee the complete removal of nitrosamines and their precursors, a well-designed system should significantly reduce the risk of their presence or formation. Users can employ a control strategy by applying a risk-based approach to assess the potential presence of nitrosamine impurities in drinking water and the system’s ability to remove them.
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