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Oxazepam
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C15H11ClN2O2 286.71

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 98.0 percent and not more than 102.0 percent of C15H11ClN2O2, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification—
B: Ultraviolet Absorption 197U
Solution: 4 µg per mL.
Medium: alcohol.
Absorptivities at 229 nm, calculated on the dried basis, do not differ by more than 3.0%.
pH 791: between 4.8 and 7.0, in an aqueous suspension (1 in 50).
Loss on drying 731 Dry it at a pressure below 5 mm of mercury at 105 for 3 hours: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.3%.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 400 mg of Oxazepam, accurately weighed, to a beaker, dissolve in 100 mL of dimethylformamide, and titrate with 0.1 N tetrabutylammonium 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 mL of 0.1 N tetrabutylammonium hydroxide is equivalent to 28.67 mg of C15H11ClN2O2.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1594
Phone Number : 1-301-816-8330