Neomycin Sulfate and Dexamethasone Sodium Phosphate Cream
» Neomycin Sulfate and Dexamethasone Sodium Phosphate Cream contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin, and the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of dexamethasone phosphate (C22H30FO8P).
Packaging and storage— Preserve in collapsible tubes or in tight containers.
USP Reference standards 11—
USP Dexamethasone RS Click to View Structure
USP Dexamethasone Phosphate RS Click to View Structure
USP Neomycin Sulfate RS
Identification—
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test 201BNP.
B: The Assay preparation, prepared as directed in the Assay for dexamethasone phosphate, meets the requirements for the Identification test under Dexamethasone Sodium Phosphate Cream.
Minimum fill 755: meets the requirements.
Assay for neomycin— Proceed with Cream as directed in the Assay under Neomycin Sulfate Cream.
Assay for dexamethasone phosphate—
Alcohol–aqueous phosphate buffer, 0.05 M Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Dexamethasone Sodium Phosphate Cream.
Assay preparation— Using an accurately weighed portion of Cream, prepare as directed in the Assay under Dexamethasone Sodium Phosphate Cream.
Procedure— Proceed as directed for Procedure in the Assay under Dexamethasone Sodium Phosphate Cream. Calculate the quantity, in mg, of dexamethasone phosphate (C22H30FO8P) in the portion of Cream taken by the formula:
0.1C(rU / rS).
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 4012
Pharmacopeial Forum: Volume No. 28(4) Page 1154