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

: 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

:657-27-2

:H₂N(CH₂)₄CH(NH₂)CO₂H·HCl

:MFCD00064564

:182.65 g/mol

Environmentally Preferable:

Meets J.P. Chemical Specifications:
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Meets E.P. Chemical Specifications:
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Meets U.S.P Requirements:
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GMP Manufactured Product:
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Meets B.P. Chemical Specifications:
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CAUTION: For Manufacturing, processing or repackaging:
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Bulk Pharmaceutical Chemical:
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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

sds_MACR4933