USP 232/233

PDE, MDD and USP <232><233>

As we work with numerous pharma companies in performing screenings of drug products and their excipients/APIs, validations of methods, and/or conducting release/routine testing, a common point of discussion is the Maximum Daily Dose (MDD) or daily Serving Size. MDD is directly correlated with the Permitted Daily Exposure (PDE).  As many are aware, USP <232> defines… Read More >

USP Monographs

USP Monographs: A Resource for Compliance with Federal Standards

As many of our clients know, dietary supplements must be manufactured according to the dietary supplement Good Manufacturing Practices (cGMP) requirements.  We’ve found an article that explains the connection between the United States Pharmacopeia (USP) standards and meeting the GMP requirements, and more specifically, how the USP monographs can serve as resources for compliance with… Read More >

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