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Arginine Hydrochloride
C6H14N4O2·HCl 210.66

L-Arginine monohydrochloride.
L-(+)-Arginine monohydrochloride [1119-34-2].
» Arginine Hydrochloride contains not less than 98.5 percent and not more than 101.5 percent of C6H14N4O2·HCl, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11— USP Arginine Hydrochloride RS. USP L-Lysine Hydrochloride RS.
Identification, Infrared Absorption 197K.
Specific rotation 781S: between +21.4 and +23.6 (t = 20).
Test solution: 80 mg per mL, in 6 N hydrochloric acid.
Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 0.2% of its weight.
Residue on ignition 281: not more than 0.1%.
Sulfate 221— A 1.6-g portion shows no more sulfate than corresponds to 0.50 mL of 0.020 N sulfuric acid (0.03%).
Heavy metals, Method I 231— Proceed as directed except to dissolve 1.0 g in 20 mL of water, add 2 mL of 1 N acetic acid, and dilute with water to 25 mL (0.002%).
Chromatographic purity—
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture.
Test solution— Dissolve an accurately weighed quantity of Arginine Hydrochloride in water to obtain a solution having a concentration of 10 mg per mL.
Standard solution— Dissolve an accurately weighed quantity of USP Arginine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.05 mg per mL. [NOTE—This solution has a concentration equivalent to about 0.5% of that of the Test solution.]
System suitability solution— Prepare a solution in water containing 0.4 mg each of USP Arginine Hydrochloride RS and USP L-Lysine Hydrochloride RS per mL.
Spray reagent— Dissolve 0.2 g of ninhydrin in 100 mL of a mixture of butyl alcohol and 2 N acetic acid (95:5).
Application volume: 5 µL.
Developing solvent system— Prepare a mixture of isopropyl alcohol and ammonium hydroxide (70:30).
Procedure— Proceed as directed for Thin-Layer Chromatography under Chromatography 621. 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 minutes. Examine the plate under white light. The chromatogram obtained from the System suitability solution exhibits two clearly separated spots. Any secondary spot in the chromatogram obtained from the Test solution is not larger or more intense than the principal spot in the chromatogram obtained from the Standard solution: not more than 0.5% of any individual impurity is found, and not more than 2.0% of total impurities is found.
Chloride content— Transfer about 350 mg, accurately weighed, to a porcelain casserole, and add 140 mL of water and 1 mL of dichlorofluorescein TS. Mix, and titrate with 0.1 N silver nitrate VS until the silver chloride flocculates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of chloride: between 16.5% and 17.1% is found.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 100 mg of Arginine Hydrochloride, accurately weighed, in 3 mL of 98 percent formic acid and 50 mL of glacial acetic acid. Add 6 mL of mercuric acetate TS, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 10.53 mg of C6H14N4O2·HCl.
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 192
Pharmacopeial Forum : Volume No. 30(2) Page 449
Phone Number : 1-301-816-8389