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USP-NFUnited States Pharmacopeia National Formulary
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We propose a simple modification of the USP-NF method that addresses this problem: by assaying for flavonol aglycones pre and post hydrolysis the content of flavonol glycosides can be accurately estimated via a simple calculation.
Because of the broad-reaching impact of these new general chapters on a large number of articles in USP-NF and the introduction of limits as well as new instrumentation methods in these chapters, it will be important for manufacturers to consider the wide range of changes they must implement in order to meet the requirements of <232> and <233>.
Between yearly editions of the USP-NF manual and bi-annual revisions, pharmaceutical regulations are ever-changing, and sometimes challenging to meet.
Food grade white mineral oils must meet the following standards established by the United States Pharmacopoeia and National Formulary (USP-NF): Colorless, odorless and tasteless; Free or nearly free of fluorescence; Neutral to litmus; Pass Readily Carbonizable Substances Test; Meet limits for Polynuclear Compounds (FDA UV Test); Pass Solid Paraffin Test at 0[degrees]C.
Sabinsa has raised the quality bar for the popular adaptogen ashwagandha with Shagandha Ashwagandha Root Extract 2.5% USP from Withania somnifera, assured to comply with the US Pharmacopoeia-National Formulary (USP-NF) monograph.
General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings was published in the USP-NF on February 1, 2016.
ProTab Laboratories has been certified through a 3rd-Party auditing firm validating that all Good Manufacturing Practices (cGMP-21CFR11) established at ProTab Laboratories meet with all of the quality standards for Nutritional Supplements ANSI 173, USP-NF. ProTab Laboratories uses strict quality control protocols and established Standard Operating Procedures (SOP) at every phase of the manufacturing process to ensure that these cGMP standards are met.
The USP Annual Scientific Meeting is designed for USP-NF and USP Reference Standards customers and other USP stakeholders including pharmaceutical scientists focusing on chemistry, microbiology, biologics and biotechnology, Process Analytical Technology, excipients, dissolution and chromatography.
General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings will be published in the USP-NF next month.
USP is an authoritative source for dietary supplements GMP audits, not only because the United States Pharmacopeia-National Formulary (USP-NF) is recognized as an official compendia of scientific qualify standards for dietary supplements and ingredients, but also because of USP's leadership in the area of dietary supplement GMPs.
Having similar properties in terms of taste, solubility and mineral content compared to the trihydrate form, the dihydrate offers the advantage that it is monographed in USP-NF Dietary Supplements since 2010, said the company.
This distinction was made clear in 2007, when USP-NF proposed an informational chapter <1059> "Excipient Performance." Although not official at the time of this writing, the informational chapter emphasizes a distinction between functionality testing with its focus on performance, and monograph testing, with its focus on identity, purity, strength and quality (2).