Ampicillin for Injection
» Ampicillin for Injection contains an amount of Ampicillin Sodium equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of ampicillin (C16H19N3O4S).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1. Protect the constituted solution from freezing.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 0.15 USP Endotoxin Unit per mg of ampicillin.
Uniformity of dosage units 905: meets the requirements.
Procedure for content uniformity Perform the Assay on individual containers using Assay preparation 1 or Assay preparation 2, or both, as appropriate.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements of the tests for Identification, Crystallinity, pH, and Water under Ampicillin Sodium. It meets also the requirements under Sterility Tests 71 and for Labeling under Injections 1.
Mobile phase, Diluent, Standard preparation, Resolution solution, and Chromatographic system Prepare as directed in the Assay under Ampicillin.
Assay preparation 1 (where it is represented as being in a single-dose container)Constitute Ampicillin for Injection in an accurately measured volume of Diluent, corresponding to the volume of solvent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and quantitatively dilute with Diluent to obtain a solution containing about 1 mg of ampicillin per mL. Use this solution promptly after preparation.
Assay preparation 2 (where the label states the quantity of ampicillin in a given volume of constituted solution)Constitute 1 container of Ampicillin for Injection in a volume of Diluent, accurately measured, corresponding to the volume of solvent specified in the labeling. Quantitatively dilute an accurately measured portion of the constituted solution with Diluent to obtain a solution having a concentration of about 1 mg of ampicillin per mL. Use this solution promptly after preparation.
Procedure Proceed as directed for Procedure in the Assay under Ampicillin. Calculate the quantity, in mg, of ampicillin (C16H19N3O4S) in the container and in the volume of constituted solution taken by the formula:
(L / D)(CP / 1000)(rU / rS)in which L is the labeled quantity, in mg, of ampicillin (C16H19 N3O4S) in the container, or in the volume of constituted solution taken; D is the concentration, in mg of ampicillin (C16H19N3O4S) per mL, of Assay preparation 1 or Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, respectively, and the extent of dilution; and the other terms are as previously defined. Where the test for Uniformity of dosage units has been performed using the Procedure for content uniformity, use the average of these determinations as the Assay value.
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USP35NF30 Page 2210