1.05701
L-赖氨酸盐酸盐
EMPROVE® EXPERT, Ph. Eur., BP, JP, USP
别名:
L-Lysine monohydrochloride, Lys
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关于此项目
经验公式（希尔记法）:
C6H15ClN2O2
化学文摘社编号:
分子量:
182.65
UNSPSC Code:
12352209
EC Index Number:
211-519-9
MDL number:
产品名称
L-赖氨酸盐酸盐, EMPROVE® EXPERT, Ph. Eur., BP, JP, USP
SMILES string
[Cl-].[N+H3][C@@H](CCCCN)C(=O)O
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
agency
BP
JP
Ph. Eur.
USP
vapor pressure
<1 Pa ( 20 °C)
description
EMPROVE® EXPERT Ph Eur,BP,JP,USP
product line
EMPROVE® EXPERT
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
Quality Level
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
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
General description
Our SAFC® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.
M-Clarity Program
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
M-Clarity Program
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
存储类别
13 - Non Combustible Solids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
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