Amphetamine Sulfate Tablets
DEFINITION
Amphetamine Sulfate Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of amphetamine sulfate [(C9H13N)2·H2SO4].
IDENTIFICATION
• A. Melting Range or Temperature, Class I 
741
741
Sample:
Macerate a quantity of powdered Tablets, equivalent to 50 mg of amphetamine sulfate, with 10 mL of water for 30 min, and filter into a small flask. To the filtrate add 3 mL of 1 N sodium hydroxide. Cool to 10
–15, add 1 mL of a mixture of absolute ether and benzoyl chloride (2:1), insert the stopper, and shake well for 3 min. Filter the precipitate, wash with 15 mL of cold water, and recrystallize twice from diluted alcohol. Dry the residue at 80 for 2 h.
–15, add 1 mL of a mixture of absolute ether and benzoyl chloride (2:1), insert the stopper, and shake well for 3 min. Filter the precipitate, wash with 15 mL of cold water, and recrystallize twice from diluted alcohol. Dry the residue at 80 for 2 h.
Acceptance criteria:
The crystals of the benzoyl derivative of amphetamine melt between 131 and 135.
and 135.
• B.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Diluted acetic acid:
14 mL of glacial acetic acid in 100 mL of water
Mobile phase:
Dissolve 1.1 g of sodium 1-heptanesulfonate in 525 mL of water. Add 25 mL of diluted acetic acid and 450 mL of methanol. Adjust with glacial acetic acid to a pH of 3.3 ± 0.1. Pass through a 0.5-µm membrane filter.
Standard solution:
0.3 mg/mL of USP Dextroamphetamine Sulfate RS in 0.12 N phosphoric acid
Sample solution:
Nominally 0.3 mg/mL of amphetamine sulfate from NLT 20 finely powdered Tablets prepared as follows. Transfer a suitable amount of the powdered tablets to a suitable volumetric flask. Add 80% of the flask volume of 0.12 N phosphoric acid, and sonicate for 15 min. Dilute with 0.12 N phosphoric acid to volume. Pass through a 0.5-µm membrane filter, discarding the first 20 mL of the filtrate.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
3.9-mm × 30-cm; 10-µm packing L1
Flow rate:
2 mL/min. [Note—A 4.6-mm × 25-cm column; 5-µm packing L1 may be used with a flow rate of 1 mL/min. ]
Injection size:
50 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 3
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of amphetamine sulfate [(C9H13N)2·H2SO4] in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Dextroamphetamine Sulfate RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of amphetamine sulfate in the Sample solution (mg/mL) |
Acceptance criteria:
93.0%–107.0%
PERFORMANCE TESTS
• Dissolution, Procedure for a Pooled Sample 711
711
Medium:
Water; 500 mL
Apparatus 1:
100 rpm
Time:
45 min
Standard solution:
USP Dextroamphetamine Sulfate RS in Medium having a known concentration of USP Dextroamphetamine Sulfate RS similar to the concentration expected in the sample.
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Diluted acetic acid:
14 mL of glacial acetic acid in 100 mL of water
Mobile phase:
1.1 g of sodium 1-heptanesulfonate in 575 mL of water. Add 25 mL of Diluted acetic acid and 400 mL of methanol. Adjust with glacial acetic acid to a pH of 3.3 ± 0.1.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
3.9-mm × 30-cm; packing L1
Flow rate:
1 mL/min
Injection size:
500 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 2.0%
Analysis
Calculate the percentage of the labeled amount of amphetamine sulfate [(C9H13N)2·H2SO4] dissolved:
Result = (rU/rS) × (CS/L) × V × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| L | = | = label claim (mg/Tablet) |
| V | = | = volume of Medium, 500 mL |
Tolerances:
NLT 75% (Q) of amphetamine sulfate [(C9H13N)2·H2SO4] is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• USP Reference Standards 11
11
USP Dextroamphetamine Sulfate RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ravi Ravichandran, Ph.D.
Principal Scientific Liaison 1-301-816-8330 |
(SM42010) Monographs - Small Molecules 4 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2205
Pharmacopeial Forum: Volume No. 34(4) Page 904