Pharmaceutical feasibility of sub-visible particle analysis in parenterals with reduced volume light obscuration methods.

Volume: 85, Issue: 3, Pages: 1084 - 1087
Published: Nov 1, 2013
Abstract
The draft for a new United States Pharmacopoeia (USP) monograph {787} Sub-visible Particulate Matter in Therapeutic Protein Injections describes the analysis of sub-visible particles by light obscuration at much lower sample volumes as so far required by the European Pharmacopoeia (Ph. Eur.) and the USP for parenterals in general. Our aim was to show the feasibility of minimizing the sample expenditure required for light obscuration similar to...
Paper Details
Title
Pharmaceutical feasibility of sub-visible particle analysis in parenterals with reduced volume light obscuration methods.
Published Date
Nov 1, 2013
Volume
85
Issue
3
Pages
1084 - 1087
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