Reference Standards

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13
Apr
The Introduction of Digital Reference Standards in the Pharmaceutical Industry

The Introduction of Digital Reference Standards in the Pharmaceutical Industry

By    Apr 13, 2026    Analytics Compliance Reference Standards

While perusing the current USP <11>, USP Reference Standards, which became effective on December 1, 2025, it was noted that the USP Reference Standard description was amended to state “highly characterized physical materials or digital data demonstrated to have the appropriate qualities to support their intended use as references for comparison in compendial tests.”  The General Chapter […]

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25
Jul

How Well Do You Know Your Reference Standards?

By    Jul 25, 2023    Compliance FDA Reference Standards

Reference standards are used ubiquitously within a Quality Control laboratory and are integral to many test procedures.  A laboratory should have defined controls for the use, handling, inventory management, and characterization of these standards, as well as consulting the WHO’s Annex 3 for “General guidelines for the establishment, maintenance, and distribution of chemical reference substances,” which […]

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