Bacterial endotoxin is a Gram-negative bacterial cell wall component that is harmful to humans at threshold concentrations, and it is not expected to be in aseptically-produced pharmaceutical medicines. It has been suggested that endotoxin cannot be detected over time in certain biopharmaceutical drug product formulations containing citrate, phosphate, and polysorbate components via an unknown masking mechanism. We have generated and present data here that indicate that endotoxin can be recovered in a variety of matrices, and under various experimental conditions.
m e commercially available bacterial membrane preparation Oxyrase was examined for use in quality control laboratory procedures for culturing anaerobic microorganisms, and as a media additive forparenteral product~lling line validation by media fill to detect anaerobes. Comparison studies between Oqrase products and conventional anaerobic culturing methods were performed. m e results from the studies showed Oxyrase for Broth to be effective in promoting the growth of anaerobes in nonprereduced media not normally used for anaerobic cultivation.
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