Amphetamine Sulfate Tablets
» Amphetamine Sulfate Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of (C9H13N)2·H2SO4.
Packaging and storage— Preserve in well-closed containers.
Identification— Macerate a quantity of powdered Tablets, equivalent to about 50 mg of amphetamine sulfate, with 10 mL of water for 30 minutes, and filter into a small flask. To the filtrate add 3 mL of 1 N sodium hydroxide. Cool to about 10 to 15, add 1 mL of a mixture of 1 volume of benzoyl chloride and 2 volumes of absolute ether, insert the stopper, and shake well for 3 minutes. Filter the precipitate, wash with about 15 mL of cold water, and recrystallize twice from diluted alcohol: the crystals of the benzoyl derivative of amphetamine so obtained, after drying at 80 for 2 hours, melt between 131 and 135, the procedure for Class I being used (see Melting Range or Temperature 741).
Dissolution, Procedure for a Pooled Sample 711
Medium: water; 500 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
Mobile phase— Dissolve 1.1 g of sodium 1-heptanesulfonate in 575 mL of water. Add 25 mL of dilute glacial acetic acid (14 in 100) and 400 mL of methanol. Adjust by the dropwise addition of glacial acetic acid to a pH of 3.3 ± 0.1, if necessary, filter, and degas the solution. Make adjustments if necessary (see System Suitability under Chromatography 621).
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph replicate injections of the Standard solution, and record the peak responses as directed for Procedure: the relative standard deviation is not more than 2.0%.
Procedure— Inject a volume (about 500 µL) of a filtered portion of the solution under test into the chromatograph, record the chromatogram, and measure the response for the major peak. Calculate the quantity of (C9H13N)2·H2SO4 dissolved in comparison with a Standard solution having a known concentration of USP Dextroamphetamine Sulfate RS in the same medium and similarly chromatographed.
Tolerances— Not less than 75% (Q) of the labeled amount of (C9H13N)2·H2SO4 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Standard preparation— Prepare as directed under Amphetamine Assay 331.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 5 mg of amphetamine sulfate, to a 100-mL beaker, add 2 mL of hydrochloric acid solution (1 in 100), swirl gently to wet the powder thoroughly, warm on a steam bath for about 1 minute, with occasional gentle swirling, and cool. Add 3 g of purified siliceous earth, and mix until a fluffy mixture is obtained.
Procedure— Proceed as directed under Amphetamine Assay 331. Calculate the quantity, in mg, of (C9H13N)2·H2SO4 in the portion of Tablets taken by the formula:
0.01C[(AU257 AU280) / (AS257 AS280)]
in which C is the concentration, in µg per mL, of USP Dextroamphetamine Sulfate RS in the Standard preparation.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 1547
Pharmacopeial Forum: Volume No. 34(4) Page 904
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.