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Endotoxins in ophthalmic viscosurgical devices.
2003
Purpose To measure the endotoxin concentration (EC) of 25 commercially available, hyaluronic acid- and hydroxypropylmethylcellulose-based (HPMC) ophthalmic viscosurgical devices (OVDs). Methods The in vitro Limulus amebocyte lysate (LAL) assay, which indicates the presence of endotoxins originating from gram-negative bacteria, was used to determine the EC. The procedure was performed according to the European Pharmacopoeia/USP. EC including duplicate determinations, negative controls, dilution series with control standard endotoxin, dilution series with sample extract and positive sample control. Results 16 OVDs (Amvisc®, Amvisc® Plus, Biolon®, Coatel®, Healon®, Healon® GV, Healon®5, HPMC O…