USP Pharmaceutical 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.  Therefore, pharmaceutical water testing is a critical to the quality control of the pharmaceutical product. 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 and conductivity.  Ion concentration is determined by conductivity while TOC measure the presence or organic carbon.

Cleaning validation extractions, swab samples, and tab water can also be tested using USP test methods and PBL typically reports these results without a reference to a specification.

Water Endotoxin Testing

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. The microbiology lab at Pacific BioLabs is experienced in performing all types of USP water testing.

Available Pharmaceutical Water Testing Services

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

Read More About USP Water Testing

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