USP 621 Archives - SCIENCE UNFILTERED

Core-Shell Technology Improves HPLC Methods Within USPFeaturedJeff Layne, Ph.D.- LC Product Manager and Technical SpecialistLiquid Chromatography (LC)Pharma / Biopharma

Using Core-Shell Technology to Improve HPLC Methods within USP: Part 1

September 27, 2017October 10, 2017 Science UnfilteredLeave a comment

U.S. Pharmacopeia

Harnessing the Power of Core-Shell Technology to Improve Older, Validated HPLC Methods Within Acceptable USP Guidelines Part One: Quality Control Methods Guest Author: Dr. Jeff Layne Hello everyone, I hope Continue Reading

Tagged Allowable Adjustments,Core-shell technology,HPLC Methods,Quality Control,The United States Pharmacopoeia,USP 621

FeaturedLiquid Chromatography (LC)Pharma / BiopharmaTechnical Tips

Revision of European Pharmacopeia (EP) Chapter 2.2.46

September 13, 2017September 22, 2017 Science UnfilteredLeave a comment

pharmaceutical

The European Pharmacopeia (EP) Chapter 2.2.46 contains information that is similar to the USP Chapter 621. Guest Author: Heiko Behr This includes general information about all chromatographic separations techniques, system Continue Reading

Tagged Allowable Adjustments to USP Methods,European Pharmacopoeia,HPLC,USP 621,USP Monograph

FeaturedPharma / BiopharmaTechnical Tips

What is USP Chapter 621?

June 28, 2017August 16, 2017 Science Unfiltered2 Comments

The United States Pharmacopeia (USP) has defined the limits of “allowable adjustments” in USP General Chapter <621>, where revalidation is required if adjustment limits are exceeded. Even though this chapter Continue Reading

Tagged guard columns,Pharmaceutical,Pharmacopeia,system suitability,USP,USP 621

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