Oxacillin Sodium for Oral Solution
» Oxacillin Sodium for Oral Solution contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of oxacillin (C19H19N3O5S). It contains one or more suitable buffers, colors, flavors, preservatives, and stabilizers.
Packaging and storage—
Preserve in tight containers at controlled room temperature.
USP Reference standards 
11
—
11—
USP Oxacillin Sodium RS 
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Identification—
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.
Uniformity of dosage units 905—
905—
for solid packaged in single-unit containers:
meets the requirements.
Deliverable volume 698:
meets the requirements.
698:
meets the requirements.
pH 791:
between 5.0 and 7.5, in the solution constituted as directed in the labeling.
791:
between 5.0 and 7.5, in the solution constituted as directed in the labeling.
Water, Method I 921:
not more than 1.0%.
921:
not more than 1.0%.
Assay—
Mobile phase
and Chromatographic system—Proceed as directed in the Assay under Oxacillin Sodium.
Diluent—
Prepare a mixture of water and acetonitrile (700:300).
Standard preparation—
Prepare a solution of USP Oxacillin Sodium RS in Diluent having a known concentration of about 0.11 mg per mL. [note—Use this solution on the day prepared. ]
Assay preparation—
Transfer an accurately measured volume of Oxacillin Sodium for Oral Solution, constituted as directed in the labeling, equivalent to about 250 mg of oxacillin (C19H19N3O5S), to a 250-mL volumetric flask, dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with Diluent to volume, and mix. Filter about 5 mL of this solution through a 0.5-µm or finer porosity filter, discarding the first 2 mL of the filtrate. Use the clear filtrate as the Assay preparation. [note—Use this Assay preparation on the day prepared. ]
Procedure—
Proceed as directed for Procedure in the Assay under Oxacillin Sodium. Calculate the quantity, in mg, of oxacillin (C19H19N3O5S) in each mL of the constituted Oxacillin Sodium for Oral Solution taken by the formula:
2.5(CE / V)(rU / rS)
in which V is the volume, in mL, of the constituted Oxacillin Sodium for Oral Solution taken, and the other terms are as defined therein.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4143