Articles
USP Pharmaceutical Waters, Part 2
February 26, 2009
•Featured Article: USP Pharmaceutical Waters, Part 2
By Roger Dabbah
The first article in this threepart series (in the March issue of BioProcess International) discussed in some detail the pharmaceutical bulk waters in the United States Pharmacopeia. This second installment deals with packaged waters, including sterile water for injection (WFI), bacteriostatic WFI, sterile water for inhalation, sterile water for irrigation, and sterile purified water. Sterile purified water first because it is used by a number of small manufacturers that cannot generate pharmaceutical waters for use in their processing, instead buying sterilized purified water from a vendor.
Bulk and packaged waters are distinguished from one another because bulk waters are controlled through inprocess tests detailed in USP general chapters <645> Water Conductivity and <643> Total Organic Carbon. But those tests cannot be used for packaged waters because extractables from their containers — either glass or plastic — interfere with the procedures. Instead, procedures historically used for packaged waters are essentially "wet chemistry" tests. The USP Expert Committee on Pharmaceutical Waters is actively exploring use of conductivity and total organic carbon (TOC) tests with specifications appropriate for bulk waters.
Click Here To Download:•Featured Article: USP Pharmaceutical Waters, Part 2
