L(+)-Lysine monohydrochloride 98.5-101.5% (dried basis), GenAR® USP, Multi-Compendial, Macron Fine Chemicals™

Supplier: Avantor Performance Materials

Synonyms: Lysine Hydrochloride, (S)-(+)-2,6-Diaminohexanoic acid monohydrochloride, L-Lysine monohydrochloride, H-Lys-OH·HCl, L-Lysine monohydrocholoride, L-Lysine Hydrochloride, (S)-(+)-Lysine monohydrochloride, (S)-(+)-2,6-Diaminocaproic acid monohydrochloride, H-Lys-OH.HCl

4933-09EA 8920 GBP
4933-09 MACR4933-06
L(+)-Lysine monohydrochloride 98.5-101.5% (dried basis), GenAR® USP, Multi-Compendial, Macron Fine Chemicals™
L(+)-Lysine monohydrochloride
Formula: H₂N(CH₂)₄CH(NH₂)CO₂H·HCl
MW: 182,65 g/mol
MDL Number: MFCD00064564
CAS Number: 657-27-2

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Specification Test Results

Meets J.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets U.S.P Requirements
GMP Manufactured Product
Meets B.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (C₆H₁₄N₂O₂·HCl) (dried basis) 98.5 - 101.5 %
USP - Identification Passes Test
USP - Specific Rotation [Å]²⁵ ^D (+) 20.4 - 21.4 Degree
USP - Loss on Drying at 105°C ≤0.4 %
USP - Residue on Ignition ≤0.1 %
USP - Sulfate (SO₄) ≤0.03 %
USP - Iron (Fe) ≤0.003 %
USP - Related Compounds - Individual Impurities ≤0.5 %
USP - Related Compounds - Total Impurities ≤2.0 %
USP - Chloride (Cl) 19.0 - 19.6 %
EP/BP - Assay (C₆H₁₄N₂O₂·HCl) (dried basis) 98.5 - 101.0 %
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Identification E Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Specific Rotation [Å]²º^D (+) 21.0 - 22.5 Degree
EP/BP-Ninhydrin-Positive Substances-Each ≤0.2 %
EP/BP-Ninhydrin-Positive Substances-Total Impurities ≤1.0 %
EP/BP - Sulfate (SO₄) ≤300 ppm
EP/BP - Ammonium (NH₄) ≤0.02 %
EP/BP - Iron (Fe) ≤30 ppm
EP/BP - Loss on Drying at 105°C ≤0.5 %
EP/BP - Ash (sulfated) ≤0.1 %
JP - Assay (C₆H₁₄N₂O₂·HCl) (dried basis) 98.5 - 101.0 %
JP - Identification A Passes Test
JP - Identification B Passes Test
JP - Optical Rotation (+) 19.0 - 21.5 Degree
JP - pH (1 in 10) 5.0 - 6.0
JP - Clarity and Color of Solution Passes Test
JP - Sulfate (SO₄) = 0.028 %
JP - Ammonium (NH₄) ≤0.02 %
JP - Heavy Metals (as Pb) ≤10 ppm
JP - Arsenic (As) ≤2 ppm
JP - Related Substances Passes Test
JP - Loss on Drying at 105°C = 1.0 %
JP - Residue on Ignition = 0.10 %
Endotoxin Concentration, IU/mg, For Information Only 19.0 - 21.5 Degree
No Class 1,2,3 or other solvents are used or produced in the 5.0 - 6.0
manufacturing or purification of the product. Passes Test
Elemental Impurities (USP (232), EP 5.20) - Information on elemental = 0.02 %
impurities for this product is available on the associated Product = 10 ppm
Regulatory Data Sheet and elemental impurity profile report. = 2 ppm
Endotoxin Concentration, IU/mg For Information Only

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