Acetohexamide
;)
Benzenesulfonamide,4-acetyl-N-[[cyclohexylamino]carbonyl]-.
1-[(p-Acetylphenyl)sulfonyl]-3-cyclohexylurea [968-81-0].
»Acetohexamide contains not less than 97.0percent and not more than 101.0percent of C15H20N2O4S,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
0.01Nsodium hydroxide.
Absorptivities at 247nm,calculated on the dried basis,do not differ by more than 3.0%.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 1.0%of its weight.
for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Selenium á291ñ:
0.003%,a 200-mg specimen mixed with 200mg of magnesium oxide being used.
Heavy metals,Method IIá231ñ:
0.002%.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Solvent:
dimethyl sulfoxide.
Assay—
Dissolve about 300mg of Acetohexamide,accurately weighed,in 40mLof dimethylformamide,add 5drops of thymol blue TS,and titrate,using a magnetic stirrer,with 0.1Nsodium methoxide VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsodium methoxide is equivalent to 32.44mg of C15H20N2O4S.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 43
Pharmacopeial Forum:Volume No.27(3)Page 2501
Phone Number:1-301-816-8251