Oxazepam
;)
2H-1,4-Benzodiazepin-2-one,7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-,(±)-.
(±)-7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one [604-75-1].
»Oxazepam contains not less than 98.0percent and not more than 102.0percent of C15H11ClN2O2,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
4µg per mL.
Medium:
alcohol.
Absorptivities at 229nm,calculated on the dried basis,do not differ by more than 3.0%.
pHá791ñ:
between 4.8and 7.0,in an aqueous suspension (1in 50).
Loss on drying á731ñ—
Dry it at a pressure below 5mm of mercury at 105
for 3hours:it loses not more than 2.0%of its weight.
for 3hours:it loses not more than 2.0%of its weight.
Residue on ignition á281ñ:
not more than 0.3%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Transfer about 400mg of Oxazepam,accurately weighed,to a beaker,dissolve in 100mLof dimethylformamide,and titrate with 0.1Ntetrabutylammonium hydroxide VS,determining the endpoint potentiometrically using a calomel-glass electrode system and taking precautions against absorption of atmospheric carbon dioxide.Perform a blank determination,and make any necessary correction.Each mLof 0.1Ntetrabutylammonium hydroxide is equivalent to 28.67mg of C15H11ClN2O2.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1428
Phone Number:1-301-816-8330