Quality Standards: USP25, FCCIV
Packaging and Storage: In 25kgs f iber drum double polyethylene bags inside or 25kgs paper bags; Preserve in well-closed containers, at controlled room temperature.
Recommended limit: 2 year.
Chemical Formula
C6H14O2N2 HCl
Molecular Weight
182.65
[Compositional Specifications of L-Lysine Monohydrochloride]
Content
L-Lysine Monohydrochloride, when dried, should contain not less than 98.0% of L-lysine monohydrochloride (C6H14O2N2 · HCl).
Description
L-Lysine Monohydrochloride occurs as a white powder or crystal powder. It is odorless or has a light, characteristic odor.
Identification
(1) To 5 ml of an aqueous solution of L-Lysine Monohydrochloride (1→100), add 1 ml of ninhydrin solution), and heat for 3 minutes. This solution become to violet.
(2) L-Lysine Monohydrochloride shows a reaction of chloride in identification.
Purity
(1) Clarity of Solution : When 0.5 g of L-Lysine Monohydrochloride is dissolved in 10 ml of water, the solution should be colorless and almost clear.
(2) Specific rotation : After drying, approximately 4 g of dried L-Lysine Monohydrochloride is precisely weighed and dissolved in 6N hydrochloric acid to make 50 ml. Optical rotation of this solution is measured, It is [α](20, D) = +19.0 ∼ +21.5°.
(3) Arsenic : When 0.25 g of L-Lysine Monohydrochloride is dissolved in 5 ml of water and the solution is tested for arsenic, its content should not be more than 4ppm.
(4) Heavy metals : 1 g of L-Lysine Monohydrochloride is dissolved in 2 ml of dilute acetic acid and approximately 30 ml of water, Use as the test Solution. This Test Solution is tested for heavy metals and its content should not be more than 10ppm.
Loss on Drying
When L-Lysine Monohydrochloride is dried for 3 hours at 105°, the weight loss should not be more than 1%.
Residue on Ignition
When thermogravimetric analysis is done with L-Lysine Monohydrochloride, the residue should not be more than 0.2%.
Assay
After drying, approximately 0.2 g of L-Lysine Monohydrochloride is precisely weighed and dissolved in 3 ml of formic acid. After adding 50 ml of glacial acetic acid and 5 ml of mercury II acetate-glacial acetic acid solution (3→50) to this solution, it is titrated with 1N perchloric acid (indicator : 0.5 ml of α-naphthol benzene). The end point is where the solution changes its color from brown to green. Separately, a blank test is carried out by the same method.
0.1 N perchloric acid 1 ml = 9.133 mg C6H14O2N2 HCl
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