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Injectable routes carry a particular concern for immunogenicity from peptide aggregation and impurities, and FDA noted the available certificates of analysis for AOD-9604 bulk drug substances did not consistently control for impurities, aggregates, or microbial limits

[22] Each 1 mL of Lipo-B injection typically contains approximately 25 mg of methionine, 50 mg of choline chloride, and 1 mg of cyanocobalamin (vitamin B), provided in multi-dose vials by compounding pharmacies

coli O157:H7 through both bamA-dependent and independent mechanisms

Certificates of Analysis are issued per lot and made available on request