Sulfapyridine Tablets
»Sulfapyridine Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of C11H11N3O2S.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
Triturate a quantity of finely powdered Tablets,equivalent to about 500mg of sulfapyridine,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 sulfapyridine is formed.Collect the precipitate on a filter,wash it well with cold water,and dry at 105
for 1hour:the sulfapyridine so obtained melts between 189and 192as determined by the method for Class Iaunder Melting Range or Temperature á741ñ,and responds to the Identificationtests under Sulfapyridine.
for 1hour:the sulfapyridine so obtained melts between 189and 192as determined by the method for Class Iaunder Melting Range or Temperature á741ñ,and responds to the Identificationtests under Sulfapyridine.
Dissolution á711ñ—
Medium:
0.01Nhydrochloric acid;900mL.
Apparatus 2:
50rpm.
Time:
60minutes.
Procedure—
Determine the amount of C11H11N3O2Sdissolved 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 Sulfapyridine RSin the same media.
Tolerances—
Not less than 70%(Q)of the labeled amount of C11H11N3O2Sis dissolved in 60minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Weigh and finely powder not less than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 500mg of sulfapyridine,and proceed as directed under Nitrite Titration á451ñ,beginning with “and transfer to a suitable open vessel.”Each mLof 0.1Msodium nitrite is equivalent to 24.93mg of C11H11N3O2S.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1832
Phone Number:1-301-816-8394