Arginine Tablets
DEFINITION
Arginine Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of arginine or arginine hydrochloride in an amount equivalent to arginine (C6H14N4O2).
IDENTIFICATION
• A. Thin-Layer Chromatographic Identification Test 
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Standard solution:
1.5 mg/mL of USP l-Arginine RS or USP Arginine Hydrochloride RS in water
Sample solution:
Weigh and finely powder NLT 20 Tablets, mix, and transfer a portion of the powder, equivalent to about 150 mg of arginine, to a 100-mL volumetric flask, add 80 mL of water, sonicate for 15 min, dilute with water to volume, mix, and filter.
Application volume:
5 µL
Developing solvent system:
Isopropyl alcohol and ammonium hydroxide (7:3)
Spray reagent:
2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
Analysis:
Proceed as directed for Chromatography 621, Thin-Layer Chromatography. Dry the plate at 100
–105 until the ammonia disappears completely. Spray with the Spray reagent, and heat at 100–105 for about 15 min. Examine the plate under white light.
621, Thin-Layer Chromatography. Dry the plate at 100–105 until the ammonia disappears completely. Spray with the Spray reagent, and heat at 100–105 for about 15 min. Examine the plate under white light.
Acceptance criteria:
The principal spot from the Sample solution corresponds in appearance and RF value to that from the Standard solution.
• B.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in Strength.
STRENGTH
• Procedure
Buffer:
6.9 mg/mL of monobasic sodium phosphate in water. Adjust with phosphoric acid to a pH of 3.5.
Solution A:
0.5 mg/mL of 1-octanesulfonic acid sodium salt in Buffer
Mobile phase:
Solution A and acetonitrile (95:5)
Standard solution:
1.5 mg/mL of USP l-Arginine RS or USP Arginine Hydrochloride RS in Buffer
Sample solution:
Weigh and finely powder NLT 20 Tablets, mix, and transfer a portion of the powder, equivalent to about 150 mg of arginine, to a 100-mL volumetric flask, add 80 mL of Buffer, sonicate for 15 min, dilute with Buffer to volume, mix, and filter.
Chromatographic system
Mode:
LC
Detector:
UV 215 nm
Column:
4.6-mm × 25-cm; packing L7
Flow rate:
0.8 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 1500 theoretical plates
Relative standard deviation:
NMT 2.0% from the arginine peak, in repeated injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of arginine 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 the Standard solution (mg/mL) |
| CU | = | = nominal concentration of Arginine in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0% of the labeled amount of arginine (C6H14N4O2)
PERFORMANCE TESTS
• Disintegration and Dissolution of Dietary Supplements 2040:
Meet the requirements for Dissolution
2040:
Meet the requirements for Dissolution
Medium:
0.1 N hydrochloric acid; 900 mL
Apparatus 2:
100 rpm
Time:
60 min
Standard solution:
Proceed as directed in the Procedure for Strength.
Sample solution:
Sample per Disintegration and Dissolution of Dietary Supplements 2040. Dilute with Medium to a concentration similar to that of the Standard solution.
2040. Dilute with Medium to a concentration similar to that of the Standard solution.
Analysis:
Determine the amounts of arginine dissolved in the Procedure for Strength, making any necessary modifications.
Tolerances:
NLT 75% of the labeled amount of arginine (C6H14N4O2) is dissolved.
• Weight Variation of Dietary Supplements 2091:
Meet the requirements
2091:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• Labeling:
The label states the form of arginine that is used and the equivalent amount of arginine.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova
Scientific Liaison 1-301-816-8328 |
(DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1192
Pharmacopeial Forum: Volume No. 36(1) Page 147