MilliporeSigma

1.05701

SAFC

L-Lysine monohydrochloride

EMPROVE® ESSENTIAL Ph Eur,BP,USP

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

Agency

BP
Ph. Eur.
USP

Quality Level

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

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assay

98.5-101.0% (alkalimetric)

assay

98.5-101.0% dry basis (alkalimetric)

assay

-

assay

-

form

solid

form

crystalline powder

form

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form

solid

mp

262 °C

mp

168-170 °C

mp

297-298 °C (decomposition)

mp

217-220 °C (dec.) (lit.)

solubility

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solubility

650 g/L

solubility

0.38 g/L

solubility

-

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

-

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.

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

Storage Class Code

13 - Non Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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