Articles
USP Pharmaceutical Waters, Part 1
February 27, 2009
•Featured Article: USP Pharmaceutical Waters, Part 1
By Roger Dabbah
Water is used many different ways in the pharmaceutical and biotechnology industries. It is used as an excipient for drugs and biologicals and thus is a component of such products. It is used for the preparation of reagents in laboratories involved in release of products or in research and development (R&D). It also is used in large quantities for cleaning and sanitizing of equipment and manufacturing facilities. The quality of water necessary for each application differs depending on the nature of the applications and the compendial and regulatory requirements in effect. The importance of water quality on finished products is such that water is one of the top ten areas that receives significant attention from FDA inspectors (see the "Expert Committee" box).
The history of water-related discussions in the US Pharmacopeia began with the first edition of USP in 1820, which contained a monograph for Aqua Distillata or Distilled Water (in USP 0, monographs were presented on facing pages in Latin and English). Since 1820, water requirements have generally paralleled advancing technologies in analytical methodologies.
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