Dextroamphetamine Sulfate Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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1 DEFINITION 

Dextroamphetamine Sulfate Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of dextroamphetamine sulfate [(C₉H₁₃N)₂ . H₂SO₄]. 

2 IDENTIFICATION 

2.1 A. 

Sample: Nominally 50 mg of dextroamphetamine sulfate from a portion of nely ground Tablets 

Analysis: Transfer the Sample to a suitable centrifuge tube. Add 25 mL of water, shake vigorously, and centrifuge until clear. Decant the clear solution into a 250-mL separator, add 5 mL of 2.5 N sodium hydroxide, and extract with 60 mL of ether. Wash the ether extract with two 5- mL portions of 0.25 N sodium hydroxide, and discard the washings. Filter the ether extract through a pledget of cotton, previously saturated with ether, into a 100-mL beaker, and evaporate on a steam bath in a current of air to 1 mL. Dissolve the residue in 3 mL of alcohol, and transfer to a glass-stoppered, 125-mL conical ask containing 25 mL of water. Rinse the beaker with 3 mL of alcohol, and transfer to the ask. Cool to 15°, add 3 mL of 1 N sodium hydroxide, then add 1 mL of a mixture of 1 volume of benzoyl chloride and 2 volumes of anhydrous ethyl ether, and shake for 2 min. Filter the precipitate, wash with 15 mL of cold water, and recrystallize twice from diluted alcohol to obtain the benzoyl derivative of dextroamphetamine. Dry the crystals at 105° for 1 h. 

Acceptance criteria: The crystals melt between 154° and 160°. 

2.2 B.

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. 

3 ASSAY 

3.1 Procedure 

Solution A: Glacial acetic acid in water (14 in 100) 

Mobile phase: Dissolve 1.1 g of sodium 1-heptanesulfonate in 525 mL of water. Add 25 mL of Solution A and 450 mL of methanol. Adjust dropwise, if necessary, with glacial acetic acid to a pH of 3.3 ± 0.1. Pass through a membrane lter of 0.5-µm pore size. Diluent: 0.12 N phosphoric acid 

Standard solution: 0.3 mg/mL of USP Dextroamphetamine Sulfate RS in Diluent 

Sample solution: Nominally 0.3 mg/mL of dextroamphetamine sulfate from NLT 20 Tablets prepared as follows. Finely powder NLT 20 Tablets, and transfer a portion of the powder, equivalent to 15 mg of dextroamphetamine sulfate, to a 50-mL volumetric ask. Add 40 mL of Diluent, and sonicate for 15 min. Dilute with Diluent to volume. Pass through a membrane lter of 0.5-µm pore size, discarding the rst 20 mL of the ltrate. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 254 nm 

Column: 3.9-mm × 30-cm; packing L1 

Flow rate: 2 mL/min 

Injection volume: 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 dextroamphetamine sulfate [(C₉H₁₃N)₂ . H₂SO₄] in the portion of Tablets taken: 

Result = (r_u/r_s) x (C_s/C_u) × 100 

r_u = peak response from the Sample solution 

r_s = peak response from the Standard solution 

C_s = concentration of USP Dextroamphetamine Sulfate RS in the Standard solution (mg/mL) 

C_u = nominal concentration of dextroamphetamine sulfate in the Sample solution (mg/mL) 

Acceptance criteria: 93.0%–107.0% 

4 PERFORMANCE TESTS 

4.1 Dissolution 〈711〉 

Procedure for a pooled sample 

Medium: Water; 500 mL 

Apparatus 1: 100 rpm 

Time: 45 min 

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. 

Standard solution: USP Dextroamphetamine Sulfate RS in Medium 

Sample solution: Pass a portion of the solution under test through a suitable lter. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 210 nm 

OFFICIAL 

Column: 3.9-mm × 30-cm; packing L1 

Column temperature: 40° 

Flow rate: 1.5 mL/min 

Injection volume: 100 µL 

System suitability 

Sample: Standard solution 

Suitability requirements 

Relative standard deviation: NMT 2.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of dextroamphetamine sulfate [(C₉H₁₃N)₂ . H₂SO₄] dissolved: 

Result = (r_u/r_s) x (C_s/C_u) × V × (1/L) × 100 

r_u = peak response from the Sample solution 

r_s = peak response from the Standard solution 

C_s = concentration of USP Dextroamphetamine Sulfate RS in the Standard solution (mg/mL) 

C_u = nominal concentration of dextroamphetamine sulfate in the Sample solution (mg/mL) 

V = volume of Medium, 500 mL 

L = label claim (mg/Tablet) 

Tolerances: NLT 75% (Q) of the labeled amount of dextroamphetamine sulfate [(C₉H₁₃N)₂ . H₂SO₄] is dissolved. 

4.2 Uniformity of Dosage Units 〈905〉: Meet the requirements 

5 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers. Store at controlled room temperature. 

USP Reference Standards 〈11〉 

USP Dextroamphetamine Sulfate RS