1.05701

L-Lysine monohydrochloride

EMPROVE^® ESSENTIAL Ph Eur,BP,USP

• Synonym(s): Lys, L-Lysine monohydrochloride
• Empirical Formula (Hill Notation): C₆H₁₅ClN₂O₂
• CAS Number: 657-27-2
• Molecular Weight: 182.65
• MDL number: MFCD00064564
• EC Index Number: 211-519-9

Properties

• Quality Level: 500
• Agency: BP; Ph. Eur.; USP
• vapor pressure: <1 Pa ( 20 °C)
• product line: EMPROVE^® ESSENTIAL
• assay: 98.5-101.0% (alkalimetric)
• form: solid
• potency: 10000 mg/kg LD₅₀, oral (Rat)
• pH: 5.5-6.0 (20 °C, 100 g/L in H₂O)
• mp: 262 °C
• solubility: 420 g/L
• density: 1.28 g/cm³ at 20 °C
• bulk density: 360 kg/m³
• storage temp.: 2-30°C
• InChI: 1S/C6H14N2O2.ClH/c7-4-2-1-3-5(8)6(9)10;/h5H,1-4,7-8H2,(H,9,10);1H/t5-;/m0./s1
• InChI key: BVHLGVCQOALMSV-JEDNCBNOSA-N

Description

Analysis Note

Assay (perchloric acid titration, calculated on dried substance): 98.5 - 101.0 %
Identity (IR-spectrum): passes test
Identity (Chloride): passes test
Appearance: white to almost white, fine powder
Appearance of solution (100 g/l, CO₂-free water): clear and not more intense in color than reference solution B₇ or GY₇
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance): +21.0 to +22.5
Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance): +20.4 to +21.4
Chloride (Cl) (argentometric): 19.0 - 19.6 %
Sulfate (SO₄): ≤ 300 ppm
Heavy metals (as Pb): ≤ 10 ppm
Fe (Iron): ≤ 30 ppm
Related Compounds, total (TLC): ≤ 0.5 %
Ninhydrin-positive substances (LC)(any ninhydrin-positive impurity): ≤ 0.2 %
Ninhydrin-positive substances (LC) (ammonium (570 nm)): ≤ 0.02 %
Ninhydrin-positive substances (LC)(total impurities): ≤ 1.0 %
Ethanol (HS-GC): ≤ 3000 ppm
Other residual solvents (ICH Q3C): excluded by manufacturing process
Sulfated ash (600 °C): ≤ 0.1 %
Loss on Drying (105 °C): ≤ 0.4 %
Bacterial endotoxins: ≤ 3.0 I.U./g
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph. Eur., BP, USP

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety Information

• Storage Class Code: 13 - Non Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable