A forensic microscopy approach for identifying subvisible particulates in a sterile ophthalmic solution

The United States Pharmacopeia (USP) states that ophthalmic solutions should be free of visible particulates upon inspection and meet the subvisible particulate matter requirements specified in USP Chapter . In this study, the authors describe a forensic microscopy approach to characterize particles...

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Veröffentlicht in:Pharmaceutical technology Europe 2017-06, Vol.29 (6), p.28
Hauptverfasser: Ciolkowski, M.L, Ingham, S.J, Glass, B.J
Format: Artikel
Sprache:eng
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Zusammenfassung:The United States Pharmacopeia (USP) states that ophthalmic solutions should be free of visible particulates upon inspection and meet the subvisible particulate matter requirements specified in USP Chapter . In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation. The particulate present in the formulation was chemically identified at low parts per million levels.
ISSN:1753-7967