Identification
A:
Dissolve about 100mg in 5mLof water,add 5mLof 1Nsodium hydroxide,cool to 10

to 15

,add 1mLof a mixture of 1volume of benzoyl chloride and 2volumes of anhydrous ethyl ether,insert the stopper,and shake for 3minutes.Filter the precipitate,wash it with about 10mLof cold water,and recrystallize it from diluted alcohol:the crystals of the benzoyl derivative of dextroamphetamine so obtained,after being dried at 105

for 1hour,melt between 155

and 160

.
B:
Asolution (1in 10)responds to the tests for Sulfate á191ñ.
Change to read:
Chromatographic purity
Diluent
Dilute 3.12mLof phosphoric acid with water to 1000mL.
Buffer solution
Dissolve 2.16g of sodium 1-octanesulfonate in 1000mLof water,and add 1.0mLof

triethylamine.
USP28Mix,and adjust with phosphoric acid to a pHof 2.5.
Mobile phase
Prepare a filtered and degassed mixture of
Buffer solution,acetonitrile,and methanol (144:37:19).Make adjustments if necessary (see
System Suitability under
Chromatography á621ñ).
Standard stock solution
Dissolve an accurately weighed quantity of
USP Dextroamphetamine Sulfate RSin
Diluent to obtain a solution having a known concentration of about 0.3mg per mL.
Standard solution
Dilute an accurately measured volume ofStandard stock solution inDiluent to obtain a solution having a known concentration of about 0.003mg per mL.
Test solution
Transfer about 30mg of Dextroamphetamine Sulfate,accurately weighed,to a 100-mLvolumetric flask.Dissolve in 50mLofDiluent,sonicate for 5minutes,dilute withDiluent to volume,and mix.
Chromatographic system(see Chromatography á621ñ)
The liquid chromatograph is equipped with a 215-nm detector and a 4.6-mm ×15-cm column that contains 5-µm packing L1.The flow rate is about 1mLper minute.Chromatograph the
Standard stock solution,and record the peak responses as directed for
Procedure:the tailing factor is not more than 2.0;and the relative standard deviation for replicate injections is not more than 2.0%.Chromatograph the
Test solution,and record the peak responses as directed for
Procedure:the resolution,
R,between the dextroamphetamine peak and any adjacent peak is not less than 1.5.
Procedure
Separately inject equal volumes (about 50µL)of the
Standard solution and the
Test solution into the chromatograph,record the chromatograms,and measure the peak responses.Calculate the percentage of each impurity in the portion of Dextroamphetamine Sulfate taken by the formula:
10,000(C/W)(ri/rS),
in which
Cis the concentration,in mg per mL,of
USP Dextroamphetamine Sulfate RSin the
Standard solution;Wis the weight,in mg,of Dextroamphetamine Sulfate taken to prepare the
Test solution;riis the peak response for each impurity obtained from the
Test solution;and
rSis the peak response for amphetamine obtained from the
Standard solution:not more than 0.1%of any individual impurity is found;and not more than 0.5%of total impurities is found.