Thiamine Mononitrate Elixir (Current title—not to change until June 1,2005) Monograph title change—to become official June 1,2005 See Thiamine Mononitrate Oral Solution »Thiamine Mononitrate Elixir contains not less than 95.0percent and not more than 115.0percent of the labeled amount of C12H17N5O4S. Packaging and storage— Preserve in tight,light-resistant containers. USP Reference standards á11ñ USP Thiamine Hydrochloride RS. Identification— A: It responds to Identificationtest Bunder Thiamine Hydrochloride Injection. B: To 5mLof Elixir add 2mLof sulfuric acid,cool,and superimpose 2mLof ferrous sulfate TS:a brown ring is produced at the junction of the two liquids. Alcohol content,Method IIá611ñ: between 90.0%and 110.0%of the labeled amount of C2H5OH,acetone being used as the internal standard. Assay— Mobile phase,Internal standard solution,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder Thiamine Hydrochloride Elixir. Assay preparation— Dilute an accurately measured volume of Elixir quantitatively with Mobile phaseto obtain a solution containing about 500µg of thiamine mononitrate per mL.Pipet 10mLof the resulting solution and 10mLof Internal standard solutioninto a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix. Procedure— Proceed as directed for Procedurein the Assayunder Thiamine Hydrochloride Elixir.Calculate the quantity,in mg,of C12H17N5O4Sin each mLof the Elixir taken by the formula: (327.36/337.27)C(L/D)(RU/RS), in which 327.36and 337.27are the molecular weights of thiamine mononitrate and thiamine hydrochloride,respectively;Cis the concentration,in mg per mL,of USP Thiamine Hydrochloride RSin the Standard preparation;Lis the labeled quantity,in mg per mL,of thiamine mononitrate in the Elixir;Dis the concentration,in mg per mL,of thiamine mononitrate in the Assay preparationon the basis of the labeled quantity and the extent of dilution;and RUand RSare the ratios of the peak responses of thiamine to methylparaben obtained from the Assay preparationand the Standard preparation,respectively. Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist Expert Committee:(DSN)Dietary Supplements:Non-Botanicals USP28–NF23Page 1909 Pharmacopeial Forum:Volume No.28(2)Page 381 Phone Number:1-301-816-8389