KEY POINTS REGARDING USP WATER

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Quality Standards: USP Water must meet specific quality standards as outlined in the USP and NF. These standards include purity, microbial content, chemical composition, and other parameters.

Purified Water: USP Water includes Purified Water (PW), which is produced through various purification processes like distillation, deionization, or reverse osmosis. Purified Water is used for general pharmaceutical purposes such as cleaning equipment, dissolving or diluting drugs, and as an excipient in formulations.

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WATER FOR INJECTION (WFI)

USP Water also includes Water for Injection (WFI), which is a highly purified water grade produced through distillation or other methods. WFI meets more stringent quality standards and is used as a solvent in the preparation of parenteral drugs (drugs administered through injection) and other critical pharmaceutical applications.

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QUALITY CONTROL

The production and use of USP Water are subject to strict quality control measures. This includes regular monitoring and testing for various parameters, including microbial content, conductivity, total organic carbon (TOC), and endotoxin levels.

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USP WATER STORAGE AND DISTRIBUTION

USP Water is typically stored in high-quality stainless-steel or poly tanks or distribution systems made of materials that do not contaminate the water. It is distributed through sanitary piping systems to prevent contamination.

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VALIDATION AND DOCUMENTATION

Pharmaceutical companies are required to validate their USP Water systems to demonstrate that they consistently produce water of the required quality. Detailed documentation of all processes and quality control measures is essential for regulatory compliance.