USP Testing

Standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements that are manufactured, distributed, and consumed worldwide, are set by the United States Pharmacopeial Convention (USP). USP works with regulators, scientists, and practitioners around the world to develop and revise standards that help to protect public health worldwide. USP has helped to secure the quality of the American drug supply since its inception in 1820. Their standards are enforced in more than 140 countries. In the United States, USP's drug standards are enforced by the Food and Drug Administration (FDA).

At Boston Analytical, our testing services are performed using USP/EP guidelines in compliance with not only FDA guidelines, but with DEA guidelines as well. As an ISO/IEC-17025:2005 certified laboratory we are specifically granted accreditation to perform testing of pharmaceutical products and raw materials in the Chemical, Biological, and Non-destructive fields.

Below is a partial listing of the many USP testing services that we offer:

USP purified water testing services at Boston Analytical
  • Spectrophotometric Identification (ID) Test USP <197> UV-Vis, FTIR, HPLC
  • Thin Layer Chromatography (TLC) USP <201>
  • Heavy Metals USP <231> Methods I and II
  • Residue on Ignition USP <281>
  • Residual Solvents USP <467>
  • Disintegration USP <701>
  • Dissolution USP <711>
  • Loss on Drying USP <731>
  • Loss on Ignition USP <733>
  • Melting Range or Temperature USP <741>
  • Optical Rotation USP <781>
  • Osmolality / Osmolarity USP <785>
  • Particulate Matter in Injections USP <788>
  • Particulate Matter in Ophthalmics USP <789>
  • pH USP <791>
  • Specific Gravity USP <841>
  • Viscosity Testing USP <911>
  • Karl Fisher Moisture USP <921> Methods 1a and 1c
  • Microbial Enumeration Testing – USP <61>
  • Absence of Specified Microorganisms – USP <62>
  • Antimicrobial Effectiveness Testing – USP <51> Preservation Efficacy Testing (PET)
  • Biological Indicator Testing – USP <55> and USP <1035>
  • Sterility Tests USP <71>
  • General Identification Tests USP <191>
  • Total Organic Carbon (TOC) USP <643> using Sievers 900
  • Conductivity USP <645>
  • Particulate Analysis – USP <788> and USP <789>
  • Water Activity Testing
    • Volatile and Non-Volatile solids and liquids – USP <1112>
  • On-site Environmental Monitoring USP <1116>
  • Disinfectant Efficacy Studies USP <1072>
  • Water Testing USP <1231>

At Boston Analytical, we are committed to providing you with quality service, timely turnaround, unsurpassed responsiveness and, and open communication. If you are in need of a USP testing analysis that you do not see, please contact us today as this is only a small listing of what Boston Analytical offers. We look forward to working with you.