Packaging and storage—
Preserve in well-closed containers.
Specific rotation 
781S
:
between +20.4
and +21.4
.
Test solution:
80 mg per mL, in 6 N hydrochloric acid.
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%).
Chromatographic purity—
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. [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
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.
Organic volatile impurities, Method I 467:
meets the requirements.
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 C
6H
14N
2O
2·HCl.
