ETX2514 sodium Sample Clauses

ETX2514 sodium. Presentation ETX2514 sodium drug product is presented as a lyophilized cake in a sterile 10 mL xxxxx xxxxx vial, with a stopper, blue overseal, and clinical label. Composition The ETX2514 sodium sterile vials are filled with 604 to 614 mg of ETX2514 sodium salt, which is equivalent to 560 to 569 mg of ETX2514 as free acid. The vials contain an 11% to 12% overfill to enable accurate withdrawal of a 500 mg dose following reconstitution with Water for Injection. Excipients Sodium hydroxide (EP, BP, JP, NF grade), hydrochloric acid (EP, BP, JP, NF grade), Water for Injection (United States Pharmacopeia, EP grade), and nitrogen (NF) are used in the formulation of ETX2514.
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