Naftifine Hydrochloride Cream
» Naftifine Hydrochloride Cream contains not less than 90.0 percent and not more than 110.0 percent of Naftifine Hydrochloride (C21H21N·HCl) in a water-miscible base.
Packaging and storage—
Preserve in tight containers.
USP Reference standards 
11
—
11—
USP Naftifine Hydrochloride RS 
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Identification—
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation as obtained in the Assay.
Microbial enumeration tests 61 and Tests for specified microorganisms 62—
It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
61 and Tests for specified microorganisms 62—
It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755:
meets the requirements.
755:
meets the requirements.
pH 791:
between 4.0 and 6.0.
791:
between 4.0 and 6.0.
Assay—
Mobile phase, Standard preparation, and Chromatographic system—
Proceed as directed in the Assay under Naftifine Hydrochloride.
Assay preparation—
Transfer about 1000 mg of Cream, accurately weighed, to a 100-mL volumetric flask, dissolve in 60 mL of methanol, mix vigorously for 2 minutes, and dilute with methanol to volume. Heat at 45
for 5 minutes, and cool to room temperature.
for 5 minutes, and cool to room temperature.
Procedure—
Separately inject equal volumes (about 15 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 mg, of C21H21N·HCl in the portion of Cream taken by the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of USP Naftifine Hydrochloride RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 3983