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USP WATER TESTING

Water is widely used as a raw material, ingredient, and a solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients and intermediates, compendial articles, and analytical reagents. As such, all water purification systems must be monitored regularly to verify the quality of the water produced. This includes chemical purity as well as microbiological quality.

Microbiological quality is monitored through various testing processes including total heterotrophic plate count, coliforms/E. coli monitoring, or by checking for the presence of other organisms suspected to be present in a water sample. Chemical purity of water samples can be assessed quantitatively through the use of Total Organic Carbon (TOC) testing.

Relevant standards relating to pharmaceutical grade water are USP <1231> Water for Pharmaceutical Purposes, USP <643> Total Organic Carbon, and USP <645> Water Conductivity.

Some types of water must also be tested for endotoxins, for example LAL reagent water, USP Water for Injection, and water for hemodialysis. Some steam systems also require certification of low endotoxin levels. In these cases, the LAL Bacterial Endotoxin Test specified in USP <85> should be performed.

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Water Testing Services

• Total Heterotrophic Plate Count
• Coliform Test / E. coli
• Total Organic Carbon
• LAL (Kinetic Chromogenic method)
• Conductivity
• pH