Penicillin V Tablets
» Penicillin V Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled number of Penicillin V Units.
Packaging and storage— Preserve in tight containers.
Labeling— The Tablets may be labeled in terms of the weight of penicillin V contained therein, in addition to or instead of Units, on the basis that 1600 Penicillin V Units are equivalent to 1 mg of penicillin V.
Identification— The retention time of the penicillin V peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution 711—
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of penicillin V (C16H18N2O5S) by a suitable validated spectrophotometric analysis of a filtered portion of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Penicillin V Potassium RS in the same medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C16H18N2O5S is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 3.0%.
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Penicillin V.
Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 400,000 USP Penicillin V Units, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and shake for about 5 minutes. Filter a portion of this solution through a suitable filter of 0.5 µm or finer porosity, and use the filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedure in the Assay under Penicillin V. Calculate the number of USP Penicillin V Units in the portion of Tablets taken by the formula:
100CP(rU / rS)
in which the 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.
Scientist
1-301-816-8161		 (MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106		 (BPC05) Biopharmaceutics05
USP32–NF27 Page 3240
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.