Denatonium Benzoate
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Benzenemethanaminium,N-[2-[(2,6-dimethylphenyl)amino]-2-oxoethyl]-N,N-diethyl-,benzoate,monohydrate.
Benzyldiethyl[(2,6-xylylcarbamoyl)methyl]ammonium benzoate monohydrate [86398-53-0].
Anhydrous 446.59 [3734-33-6].
»Denatonium Benzoate,dried at 105
for 2hours,contains one molecule of water of hydration or is anhydrous.When dried at 105for 2hours,it contains not less than 99.5percent and not more than 101.0percent of C28H34N2O3.
for 2hours,contains one molecule of water of hydration or is anhydrous.When dried at 105for 2hours,it contains not less than 99.5percent and not more than 101.0percent of C28H34N2O3.
Packaging and storage—
Preserve in tight containers.
Labeling—
Label it to indicate whether it is hydrous or anhydrous.
Identification—
Solution:
100µg per mL.
Medium:
water.
Absorptivities at 263nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Dissolve about 150mg in 10mLof water,and add 15mLof trinitrophenol TS:a yellow precipitate is formed.
D:
Dissolve about 100mg in 10mLof water,and add 20mLof 2Nsulfuric acid and 15mLof ammonium reineckate TS.Mix,filter through a sintered-glass crucible using gentle suction,and wash thoroughly with water.Remove as much water as possible with suction,and then dry in an oven at 105for 1hour:the denatonium reineckate so obtained melts at about 170(see Melting Range or Temperature á741ñ).
for 1hour:the denatonium reineckate so obtained melts at about 170(see Melting Range or Temperature á741ñ).
pHá791ñ:
between 6.5and 7.5,in a solution (3in 100).
Loss on drying á731ñ—
Dry it at 105for 2hours:the monohydrate loses between 3.5%and 4.5%of its weight,and the anhydrous form loses not more than 1.0%of its weight.
for 2hours:the monohydrate loses between 3.5%and 4.5%of its weight,and the anhydrous form loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Chloride á221ñ—
Dissolve 350mg in 9mLof water,add 1mLof nitric acid,and filter.A1.0-mLportion of the filtrate shows no more chloride than corresponds to 0.10mLof 0.020Nhydrochloric acid (0.2%).
Assay—
Dissolve about 900mg of Denatonium Benzoate,previously dried and accurately weighed,in 50mLof glacial acetic acid,add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 44.66mg of C28H34N2O3.
Auxiliary Information—
Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2995
Phone Number:1-301-816-8262