Pharmaceutical Water Testing

  • FDA Registration FEI# 1000151293 as a GMP/GLP/GCP Drug Establishment and Cosmetic Facility.
  • DEA Registration# RC0199744 (Analytical Lab) | Schedule I-V license | Remember, Schedules I-II require DEA Form 222 | Registration# RC0171568 (Researcher)
  • US EPA/NJ DEP Registration# NJD982726648
  • ISO/IEC 17025:2017 Accreditation# 80071

Water plays a major role in the formulation, manufacturing, and processing of pharmaceutical products, active pharmaceutical ingredients (APIs), compendial articles and analytical reagents.

It is used in a variety of ways, including as an ingredient and for cleaning processing equipment. As such, water must meet appropriate specifications for its intended usage to ensure product purity and quality. Pharmaceutical manufacturers are responsible for ensuring that water used in production processes meets pharmacopeial and regulatory requirements.

USP testing methods and standards are essential for evaluating water quality and suitability for pharmaceutical applications.

It is critical that pharmaceutical manufacturers choose the appropriate water-type and testing methods for intended applications. Water systems must be validated, monitored, and maintained to ensure the continuing quality of the water and to prevent contamination/biological build-up.

For best results, qualified analytical experts like those at CPT℠ Labs should be called upon to assess the quality of pharmaceutical water and water systems.

Our Capabilities

CPT℠ maintains state-of-the-art analytical, microbiological, clinical, photobiological, and in vitro toxicological testing laboratories, all of which are at your disposal for determining the safety, quality, purity, and efficacy of your products.

Our specialized laboratories test a wide range of products and our in-house experts provide technical and regulatory guidance to ensure quality and compliance in the most cost-effective manner.

CPT℠ employs USP standards and methodologies in the testing of water and water system quality. This serves as a starting point in determining the suitability of your water for use as an ingredient in your products, or for cleaning your processing equipment.

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Don't Miss Our Upcoming Webinar

Understanding Phototoxicity and Photoallergy Testing in Product Safety Determination

Speaker: Michael Lutz
Date: October 21 at 1:00PM ET