11/6/2020 USP-NF Arginine
Printed on: Fri Nov 06 2020, 15:44:20 pm
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O cial Status: Currently O cial on 06-Nov-2020
O cial Date: O cial as of 1-May-2020
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© 2020 USPC
Arginine
C6H14N4O2 174.20
L-Arginine [74-79-3].
DEFINITION
Arginine contains NLT 98.5% and NMT 101.5% of C6H14N4O2, as L-arginine, calculated on the dried basis.
IDENTIFICATION
Change to read:
• ▲SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-MAY-2020)
ASSAY
• PROCEDURE
Sample: 80 mg of Arginine
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Direct titration
Titrant: 0.1 N perchloric acid VS L
IA
Endpoint detection: Potentiometric
Blank: 3 mL of formic acid and 50 mL of glacial acetic acid
Analysis: Dissolve the Sample in a mixture of 3 mL of formic acid and 50 mL of glacial acetic acid, and titrate with Titrant. Calculate
the percentage of C6H14N4O2 in the portion taken:
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Result = [(V − B) × N × F × 100]/W
V = Sample titrant volume (mL)
B = Blank titrant volume (mL)
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N = titrant normality (mEq/mL)
F = equivalency factor: 87.10 mg/mEq
W = weight of Sample (mg)
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Acceptance criteria: 98.5%–101.5% on the dried basis
IMPURITIES
INORGANIC IMPURITIES
• RESIDUE ON IGNITION 〈281〉: NMT 0.3%
• CHLORIDE AND SULFATE, Chloride〈221〉: A 1.0-g portion shows no more chloride than corresponds to 0.70 mL of 0.020 N hydrochloric acid
(0.05%).
• CHLORIDE AND SULFATE, Sulfate〈221〉: A 1.0-g portion shows no more sulfate than corresponds to 0.30 mL of 0.020 N sulfuric acid
(0.03%).
• IRON 〈241〉: NMT 30 ppm
ORGANIC IMPURITIES
• PROCEDURE
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture
Standard solution: 0.05 mg/mL of USP L-Arginine RS in 0.1 N hydrochloric acid. [NOTE—This solution has a concentration equivalent
to 0.5% of that of the Sample solution.]
Sample solution: 10 mg/mL of Arginine in 2 N hydrochloric acid
System suitability solution: 0.4 mg/mL each of USP L-Arginine RS and USP L-Lysine Hydrochloride RS in 0.1 N hydrochloric acid
Spray reagent: 2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
Application volume: 5 µL
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11/6/2020 USP-NF Arginine
Developing solvent system: Isopropyl alcohol and ammonium hydroxide (7:3)
Analysis
Samples: Standard solution, Sample solution, and System suitability solution
Proceed as directed under Chromatography 〈621〉, Thin-Layer Chromatography. Dry the plate between 100° and 105° until the
ammonia disappears completely. Spray with Spray reagent, and heat between 100° and 105° for about 15 min. Examine the
plate under white light. The chromatogram obtained from the System suitability solution exhibits two clearly separated spots.
Acceptance criteria
Individual impurities: Any secondary spot from the Sample solution is not larger or more intense than the principal spot from the
Standard solution, NMT 0.5%
Total impurities: NMT 2.0%
SPECIFIC TESTS
• OPTICAL ROTATION, Specific Rotation〈781S〉: +26.3° to +27.7°
Sample solution: 80 mg/mL in 6 N hydrochloric acid
• LOSS ON DRYING 〈731〉: Dry a sample at 105° for 3 h: it loses NMT 0.5% of its weight.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed containers.
• USP REFERENCE STANDARDS 〈11〉
USP L-Arginine RS
USP L-Lysine Hydrochloride RS
Auxiliary Information- Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
ARGININE Fatkhulla K Tadjimukhamedov NBDS2020 Non-botanical Dietary
Associate Scienti c Liaison
L Supplements
IA
Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:
Pharmacopeial Forum: Volume No. 44(5)
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Page Information:
USP43-NF38 - 371
USP42-NF37 - 365
USP41-NF36 - 348
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