Sulfadiazine Tablets
»Sulfadiazine Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of C10H10N4O2S.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
Triturate a quantity of finely powdered Tablets,equivalent to about 500mg of sulfadiazine,with 5mLof chloroform,and transfer to a small filter.Wash with another 5-mLportion of chloroform,and discard the filtrate.Triturate the residue with 10mLof 6Nammonium hydroxide for 5minutes,add 10mLof water,and filter.Warm the filtrate until most of the ammonia is expelled,cool,and add 6Nacetic acid until the reaction is distinctly acid:a precipitate of sulfadiazine is formed.Collect the precipitate on a filter,wash it with cold water,and dry at 105
for 1hour:the sulfadiazine so obtained melts between 250and 254,as determined by the method for Class Iaunder Melting Range or Temperature á741ñand responds to Identificationtest Aunder Sulfadiazine.
for 1hour:the sulfadiazine so obtained melts between 250and 254,as determined by the method for Class Iaunder Melting Range or Temperature á741ñand responds to Identificationtest Aunder Sulfadiazine.
Dissolution á711ñ—
Medium:
0.1Nhydrochloric acid;900mL.
Apparatus 2:
75rpm.
Time:
90minutes.
Procedure—
Determine the amount of C10H10N4O2Sdissolved by employing UVabsorption at the wavelength of maximum absorbance at about 254nm on filtered portions of the solution under test,suitably diluted with 0.01Nsodium hydroxide,in comparison with a Standard solution having a known concentration of USP Sulfadiazine RSin the same media.
Tolerances—
Not less than 70%(Q)of the labeled amount of C10H10N4O2Sis dissolved in 90minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Mobile phase
and Standard preparation—Prepare as directed in the Assayunder Sulfadiazine.
Assay preparation—
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of sulfadiazine,to a 100-mLvolumetric flask,add 75mLof 0.025Nsodium hydroxide,shake for 30minutes,dilute with 0.025Nsodium hydroxide to volume,mix,and centrifuge.
Chromatographic system
and Procedure—Proceed as directed for Chromatographic systemand for Procedurein the Assayunder Sulfadiazine.Calculate the quantity,in mg,of C10H10N4O2Sin the portion of Tablets taken by the formula:
100C(rU/rS),
in which the terms are as defined therein.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1820
Phone Number:1-301-816-8394