» Lysine Hydrochloride contains not less than 98.5 percent and not more than 101.5 percent of C6H14N2O2·HCl, as l-lysine hydrochloride, calculated on the dried basis.
Packaging and storage Preserve in well-closed containers.
Identification, Infrared Absorption 197K.
Specific rotation 781S: between +20.4 and +21.4.
Test solution: 80 mg per mL, in 6 N hydrochloric acid.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 0.4% of its weight.
Residue on ignition 281: not more than 0.1%.
Sulfate 221 A solution containing 0.33 g shows no more sulfate than corresponds to 0.10 mL of 0.020 N sulfuric acid (0.03%).
Iron 241: 0.003%.
Heavy metals, Method I 231: 0.0015%.
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture.
Test solution Dissolve an accurately weighed quantity of Lysine Hydrochloride in water to obtain a solution having a concentration of 10 mg per mL. Apply 5 µL.
Standard solution Dissolve an accurately weighed quantity of USP l-Lysine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.05 mg per mL. Apply 5 µL. [noteThis 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 l-Lysine Hydrochloride RS and USP Arginine Hydrochloride RS per mL. Apply 5 µL.
Spray reagent Dissolve 0.2 g of ninhydrin in 100 mL of a mixture of butyl alcohol and 2 N acetic acid (95:5).
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.
Content of chloride 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 19.0% and 19.6% is found.
Assay Transfer about 90 mg of Lysine Hydrochloride, accurately weighed, to a 125-mL flask, and dissolve in a mixture of 3 mL of formic acid and 50 mL of glacial acetic acid. Add 10 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 9.133 mg of C6H14N2O2·HCl.
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USP32NF27 Page 2818
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.