International Journal of Pharmaceutical Compounding

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Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations

Author(s): Allen Loyd V Jr

Issue: Nov/Dec 2023 - Volume 27, Number 6
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Page(s): 483-486

Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations Page 1

Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations Page 2

Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations Page 3

Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations Page 4

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Abstract: Inadvertent administration of endotoxins to humans may result in a number of events, ranging from fever, through a cascade of pathogenic responses, to death. Endotoxins are potent, toxic, and very stable and are present in many pharmaceutical ingredients and on surfaces that come into contact with preparations formulated for parenteral administration. Endotoxins are very difficult to eliminate in a final preparation, therefore, procedures are generally directed at eliminating endotoxins during the preparation process. This article discusses the allowable endotoxin levels in parenteral preparations.

Related Keywords: Loyd V. Allen Jr., PhD, RPh, endotoxins, parenteral preparations, injectables, compounded sterile preparations, lipopolysaccharides, endotoxin load, endotoxin limit worksheet, endotoxin limit table, United States Pharmacopeia--National Formulary, USP-NF

Related Categories: PARENTERALS, STERILE PREPARATIONS, ADVERSE DRUG EVENTS, INFORMATION RESOURCES

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