Arginine Hydrochloride (ar' ji neen hye'' droe klor' ide). DEFINITION Arginine Hydrochloride contains NLT 98.5% and NMT 101.5% of arginine hydrochloride (C6H14N4O2·HCl), calculated on the dried basis. IDENTIFICATION ASSAY • Procedure Sample: 100 mg of Arginine Hydrochloride Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: 0.1 N perchloric acid VS Endpoint detection: Potentiometric Blank: 50 mL of glacial acetic acid and 3 mL of 98% formic acid. Add 6 mL of mercuric acetate TS. Analysis: Dissolve the Sample in 3 mL of 98% formic acid and 50 mL of glacial acetic acid. Add 6 mL of mercuric acetate TS and titrate with the Titrant. Calculate the percentage of arginine hydrochloride (C6H14N4O2·HCl) in the Sample taken: Result = [(V B) × N × F × 100]/W
Acceptance criteria: 98.5%101.5% on the dried basis IMPURITIES • Residue on Ignition 281: NMT 0.1% • Chloride and Sulfate, 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 Test preparation: Proceed as directed in the chapter, 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. Acceptance criteria: NMT 20 ppm • Chromatographic Purity System suitability solution: 0.4 mg/mL each of USP Arginine Hydrochloride RS and USP l-Lysine Hydrochloride RS in water Standard solution: 0.05 mg/mL of USP Arginine Hydrochloride RS in water. [NoteThis solution has a concentration equivalent to about 0.5% of that of the Sample solution. ] Sample solution: 10 mg/mL of Arginine Hydrochloride in water Chromatographic system Mode: TLC Adsorbent: 0.25-mm layer of chromatographic silica gel mixture Application volume: 5 µL Developing solvent system: Isopropyl alcohol and ammonium hydroxide (70:30) Spray reagent: 2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5) Analysis Samples: System suitability solution, Standard solution, and Sample solution Proceed as directed in the chapter. 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 System suitability solution exhibits two clearly separated spots. Acceptance criteria: Any secondary spot from the Sample solution is not larger or more intense than the principal spot from the Standard solution. Individual impurities: NMT 0.5% Total impurities: NMT 2.0% SPECIFIC TESTS • Optical Rotation, Specific Rotation 781S: +21.4 to +23.6 (t = 20) Sample solution: 80 mg/mL in 6 N hydrochloric acid • Loss on Drying 731: Dry a sample at 105 for 2 h: it loses NMT 0.2% of its weight. • Chloride Content Sample: 350 mg of Arginine Hydrochloride Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: 0.1 N silver nitrate VS Endpoint detection: Colorimetric Blank: 140 mL of water and 1 mL of dichlorofluorescein TS Analysis: Transfer the Sample to a porcelain casserole, and add 140 mL of water and 1 mL of dichlorofluorescein TS. Mix and titrate with the Titrant until the silver chloride flocculates and the mixture acquires a faint pink color. Calculate the percentage of chloride (Cl) in the Sample taken: Result = [(V B) × N × F × 100]/W
Acceptance criteria: 16.5%17.1% ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in well-closed containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2238 Pharmacopeial Forum: Volume No. 30(2) Page 449Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |