Sulfadimethoxine Sodium
C12H13N4NaO4S 332.31
Benzenesulfonamide,4-amino-N-(2,6-dimethoxy-4-pyrimidinyl)-,monosodium salt.
N1-(2,6-Dimethoxy-4-pyrimidinyl)sulfanilamide monosodium salt [1037-50-9].
»Sulfadimethoxine Sodium contains not less than 98.0percent and not more than 102.0percent of C12H13N4NaO4S,calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers,and store at controlled room temperature.
Labeling— Label it to indicate that it is for veterinary use only.
Identification—
A: To about 100mg,add 50mLof water,mix until dissolved,and dilute with water to 100mL.To about 5mLof this solution add 100mg of phenol,and heat to boiling.Cool the solution,and add 0.5mLof sodium hypochlorite TSand 3drops of 2.5Nsodium hydroxide:a yellow color is produced.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
C: Dissolve 10mg in 2mLof diluted hydrochloric acid,add 3drops of sodium nitrite solution (1in 100),and dilute with water to 4mL:the solution turns yellow.Add 1mLof 2.5Nsodium hydroxide containing 10mg of 2-naphthol:a red-orange precipitate is formed.
pHá791ñ: between 8.0and 9.5,in a solution (1in 20).
Loss on drying á731ñ— Dry it at 105for 3hours:it loses not more than 5.0%of its weight.
Heavy metals— Dissolve 1.0g in 25mLof water,and add 5drops of freshly prepared sodium sulfide TS:any color produced is not darker than that of a control made with 23mLof water,2.0mLof Standard Lead Solution(see Heavy Metals á231ñ),and 5drops of freshly prepared sodium sulfide TS(0.002%).
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Sulfadimethoxine.
Assay preparation— Transfer about 60mg of Sulfadimethoxine Sodium,accurately weighed,to a 250-mLvolumetric flask,add about 200mLof Mobile phase,and swirl to dissolve.Dilute with Mobile phaseto volume,and mix.Protect this solution from light.
Procedure— Proceed as directed in the Assayunder Sulfadimethoxine.Calculate the quantity,in mg,of C12H13N4NaO4Sin the portion of Sulfadimethoxine Sodium taken by the formula:
(332.31/310.34)(250C)(rU/rS),
in which 332.31and 310.34are the molecular weights of sulfadimethoxine sodium and sulfadimethoxine,respectively;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1824
Pharmacopeial Forum:Volume No.28(6)Page 1872
Phone Number:1-301-816-8178