Neomycin Sulfate and Dexamethasone Sodium Phosphate Cream
»Neomycin Sulfate and Dexamethasone Sodium Phosphate Cream contains the equivalent of not less than 90.0percent and not more than 135.0percent of the labeled amount of neomycin,and the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of dexamethasone phosphate (C22H30FO8P).
Packaging and storage— Preserve in collapsible tubes or in tight containers.
Identification—
A: It meets the requirements for neomycin underThin-Layer Chromatographic Identification Test á201BNPñ.
B: TheAssay preparation,prepared as directed in theAssay for dexamethasone phosphate,meets the requirements for theIdentification test under Dexamethasone Sodium Phosphate Cream.
Minimum fill á755ñ: meets the requirements.
Assay for neomycin— Proceed with Cream as directed in theAssay under Neomycin Sulfate Cream.
Assay for dexamethasone phosphate—
Alcohol–aqueous phosphate buffer,0.05M Phosphate buffer,Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in theAssay under Dexamethasone Sodium Phosphate Cream.
Assay preparation— Using an accurately weighed portion of Cream,prepare as directed in theAssay under Dexamethasone Sodium Phosphate Cream.
Procedure— Proceed as directed forProcedure in theAssay 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— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1344
Pharmacopeial Forum:Volume No.28(4)Page 1154
Phone Number:1-301-816-8335