1.05701

L-赖氨酸盐酸盐

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

• 同義詞: L-Lysine monohydrochloride, Lys
• 經驗公式（希爾表示法）: C₆H₁₅ClN₂O₂
• CAS 編號: 657-27-2
• 分子量：: 182.65
• MDL號碼: MFCD00064564
• 分類程式碼代碼: 12352209
• 酶委員會索引編號: 211-519-9

屬性

• agency: BP; JP; Ph. Eur.; USP
• 品質等級: 500
• 蒸汽壓力: <1 Pa ( 20 °C)
• 描述: EMPROVE^® EXPERT Ph Eur,BP,JP,USP
• 產品線: EMPROVE^® EXPERT
• 化驗: 98.5-101.0% (alkalimetric)
• 形狀: solid
• 效力: 10000 mg/kg LD₅₀, oral (Rat)
• pH值: 5.5-6.0 (20 °C, 100 g/L in H₂O)
• mp: 262 °C
• 溶解度: 420 g/L
• 密度: 1.28 g/cm³ at 20 °C
• 體積密度: 360 kg/m³
• 儲存溫度: 2-30°C
• SMILES 字串: [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 密鑰: BVHLGVCQOALMSV-JEDNCBNOSA-N

描述

一般說明

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.

分析報告

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

法律資訊

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

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

安全資訊

• 儲存類別代碼: 13 - Non Combustible Solids
• 水污染物質分類（WGK）: WGK 1
• 閃點（°F）: Not applicable
• 閃點（°C）: Not applicable