1.05701

L-Lysine monohydrochloride

EMPROVE^® EXPERT, Ph. Eur., BP, JP, USP

• Sinônimo(s): L-Lysine monohydrochloride, Lys
• Fórmula empírica (Notação de Hill): C₆H₁₅ClN₂O₂
• Número CAS: 657-27-2
• Peso molecular: 182.65
• Número MDL: MFCD00064564
• Código UNSPSC: 12352209
• Número do índice EC: 211-519-9

Propriedades

• Agency: BP; JP; Ph. Eur.; USP
• Nível de qualidade: 500
• pressão de vapor: <1 Pa ( 20 °C)
• descrição: EMPROVE^® EXPERT Ph Eur,BP,JP,USP
• linha de produto: EMPROVE^® EXPERT
• Ensaio: 98.5-101.0% (alkalimetric)
• Formulário: solid
• potência: 10000 mg/kg LD₅₀, oral (Rat)
• pH: 5.5-6.0 (20 °C, 100 g/L in H₂O)
• pf: 262 °C
• solubilidade: 420 g/L
• densidade: 1.28 g/cm³ at 20 °C
• densidade volumétrica: 360 kg/m³
• temperatura de armazenamento: 2-30°C
• cadeia de caracteres SMILES: [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
• chave InChI: BVHLGVCQOALMSV-JEDNCBNOSA-N

Descrição

Descrição geral

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.

Nota de análise

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

Informações legais

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

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

Informações de segurança

• Código de classe de armazenamento: 13 - Non Combustible Solids
• Classe de risco de água (WGK): WGK 1
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable