1.08378

L-酪氨酸

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

• 别名: L-Tyrosine, 4-Hydroxyphenylalanine, Tyr
• CAS号: 60-18-4
• 分子量: 181.19
• MDL號碼: MFCD00002606
• 分類程式碼代碼: 12352209
• 酶委員會索引編號: 200-460-4

属性

• agency: ChP; JP; Ph. Eur.; USP
• 品質等級: 500
• 描述: EMPROVE^® EXPERT Ph Eur,JP,USP
• 產品線: EMPROVE^® EXPERT
• 效力: >5110 mg/kg LD₅₀, oral (Rat)
• pH值: 6.5 (0.1 g/L in H₂O)
• mp: 297-298 °C (decomposition)
• 溶解度: 0.38 g/L
• 密度: 1.46 g/cm³ at 20 °C
• 體積密度: 300 kg/m³
• 應用: parenterals
• 儲存溫度: 2-30°C
• InChI: 1S/C9H11NO3/c10-8(9(12)13)5-6-1-3-7(11)4-2-6/h1-4,8,11H,5,10H2,(H,12,13)
• InChI 密鑰: OUYCCCASQSFEME-UHFFFAOYSA-N

说明

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 ProgramAs 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)99.0 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite to almost white, crystalline powder or colorless crystalsAppearance of solution(25 g/l, Hydrochloric acid 2 mol/l)clear and not more intense in color than reference solution Y₇Spec. rotation (α 20/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-11.0 to -12.3Spec. rotation (α 25/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-9.8 to -11.2Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 300 ppmFe (Iron)≤ 10 ppmRelated Compounds, total (TLC)≤ 0.5 %Ninhydrin-positive substances (LC)(impurity A (570 nm))≤ 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)≤ 0.6 %Residual solvents (ICH (Q3C))excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Bacterial endotoxins≤ 20 I.U./gMicrobiological test (total aerobic microbial count (TAMC))≤ 100 CFU/gMicrobiological test (total yeast and mould count (TYMC))≤ 100 CFU/gElemental 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., 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

安全信息

• 儲存類別代碼: 11 - Combustible Solids
• 水污染物質分類（WGK）: WGK 1
• 閃點（°F）: Not applicable
• 閃點（°C）: Not applicable