(ox'' a sil' in soe' dee um).
4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-6-[[(5-methyl-3-phenyl-4-isoxazolyl)carbonyl]amino]-7-oxo-, monosodium salt, monohydrate, [2S-(2,5,6)]-.
Monosodium (2S,5R,6R)-3,3-dimethyl-6-(5-methyl-3-phenyl-4-isoxazolecarboxamido)-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate monohydrate [7240-38-2].
Anhydrous 423.43 [1173-88-2].
» Oxacillin Sodium contains the equivalent of not less than 815 µg and not more than 950 µg of oxacillin (C19H19N3O5S) per mg.
Packaging and storage Preserve in tight containers, at controlled room temperature.
Labeling Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards 11
USP Endotoxin RS
A: The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for oxacillin, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
B: It responds to the tests for Sodium 191.
Crystallinity 695: meets the requirements.
pH 791: between 4.5 and 7.5, in a solution containing 30 mg per mL.
Water, Method I 921: between 3.5% and 5.0%.
Other requirements Where the label states that Oxacillin Sodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Oxacillin for Injection. Where the label states that Oxacillin Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Oxacillin for Injection.
Mobile phase Dissolve 1.9 g of monobasic potassium phosphate in 700 mL of water. Add 300 mL of acetonitrile and 100 mL of methanol, and mix. Filter this solution through a 0.5-µm or finer porosity filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Dissolve an accurately weighed quantity of USP Oxacillin Sodium RS in water to obtain a solution having a known concentration of about 0.11 mg per mL. [noteUse this Standard preparation on the day prepared. ]
Assay preparation Transfer about 115 mg of Oxacillin Sodium, accurately weighed, to a 200-mL volumetric flask, add water to volume, and mix. Stir with the aid of a magnetic stirrer for 5 minutes to ensure dissolution of the specimen. Transfer 10.0 mL of this solution to a 50-mL volumetric flask, dilute with water to volume, and mix. [noteUse this Assay preparation on the day prepared. ]
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 225-nm detector and a 4-mm × 30-cm column that contains packing L11. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the responses as directed for Procedure: the column efficiency is not less than 2000 theoretical plates, the tailing factor is not more than 1.6, and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure [noteUse peak areas where peak responses are indicated. ] Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in µg, of oxacillin (C19H19N3O5S) in each mg of the Oxacillin Sodium taken by the formula:
1000(CE / W)(rU / rS)in which C is the concentration, in mg per mL, of USP Oxacillin Sodium RS in the Standard preparation; E is the oxacillin equivalent, in µg per mg, of USP Oxacillin Sodium RS; W is the weight, in mg, of the portion of Oxacillin Sodium taken; and rU and rS are the oxacillin peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4141