L-谷氨酰胺

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.

L-谷氨酰胺是一种必需氨基酸，作为细胞培养过程中主要的能量来源而成为培养基的重要组分。L-谷氨酰胺在干粉及冷冻溶液的状态下极为稳定。然而，L-谷氨酰胺在液体培养基或储存溶液中均会相对较快的降解。最佳的细胞表现通常需要在使用前向培养基中添加L-谷氨酰胺补充剂。

Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testAppearancewhite to almost white, fine powderAppearance of solution (25 g/l; CO₂-free water)clear and colorlessSpec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+31.5 to +33.0Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance)+6.3 to +7.3pH (25 g/l; CO₂-free water)4.0 - 6.0Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 200 ppmHeavy metals (as Pb)≤ 10 ppmCu (Copper)≤ 25 ppmFe (Iron)≤ 10 ppmFe (Iron) (ICP)≤ 10 ppmMn (Manganese)≤ 25 ppmNi (Nickel)≤ 2 ppmZn (Zinc)≤ 130 ppmNH₄ (Ammonium)≤ 0.1 %Ninhydrin - positive substances (TLC)≤ 0.5 %Residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Bacterial endotoxins≤ 2.0 I.U./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 DAB, USP

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

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