Nafcillin Sodium Capsules
» Nafcillin Sodium Capsules contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of nafcillin (C21H22N2O5S).
Packaging and storage—
Preserve in tight containers.
Dissolution 
711
—
711—
Medium:
water; 900 mL.
Apparatus 1:
100 rpm.
Time:
45 minutes.
Procedure—
Determine the amount of nafcillin (C21H22N2O5S) by a suitable validated spectrophotometric analysis of a filtered portion of the solution under test, suitably diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Nafcillin Sodium RS in the same medium.
Tolerances—
Not less than 75% (Q) of the labeled amount of C21H22N2O5S is dissolved in 45 minutes.
Uniformity of dosage units 905:
meet the requirements.
905:
meet the requirements.
Water, Method I 921:
not more than 5.0%.
921:
not more than 5.0%.
Assay—
Proceed as directed under Antibiotics—Microbial Assays 81, using not less than 5 Capsules blended for 4 ± 1 minutes in a high-speed glass blender jar containing an accurately measured volume of Buffer No. 1. Dilute an accurately measured volume of this stock solution quantitatively with Buffer No. 1 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
81, using not less than 5 Capsules blended for 4 ± 1 minutes in a high-speed glass blender jar containing an accurately measured volume of Buffer No. 1. Dilute an accurately measured volume of this stock solution quantitatively with Buffer No. 1 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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 3021