1.00286

L-Glutamine

EMPROVE^® EXPERT, DAB, JP, USP

• Synonyme(s) : 5-Amide d’acide L-glutamique, Acide (S)-2,5-diamino-5-oxopentanoïque, Lévoglutamide
• Formule linéaire : H₂NCOCH₂CH₂CH(NH₂)CO₂H
• Numéro CAS: 56-85-9
• Poids moléculaire : 146.14
• Numéro Beilstein : 1723797
• Numéro MDL: MFCD00008044
• Code UNSPSC : 12352209
• Numéro de classement CE : 200-292-1

Propriétés

• Agence: DAB; JP; USP
• Niveau de qualité: 500
• Description: EMPROVE^® EXPERT DAB,USP
• Gamme de produits: EMPROVE^® EXPERT
• Forme: solid
• Puissance: 7500 mg/kg LD₅₀, oral (Rat)
• Technique(s): API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 4.0-6.0 (20 °C, 25 g/L in H₂O)
• Pf: 185 °C (dec.) (lit.)
• Solubilité: 100 g/L
• Densité: 1.47 g/cm³ at 20 °C
• Masse volumique apparente: 640 kg/m³
• Température de stockage: 2-30°C
• Chaîne SMILES: N[C@@H](CCC(N)=O)C(O)=O
• InChI: 1S/C5H10N2O3/c6-3(5(9)10)1-2-4(7)8/h3H,1-2,6H2,(H2,7,8)(H,9,10)/t3-/m0/s1
• Clé InChI: ZDXPYRJPNDTMRX-VKHMYHEASA-N

Description

Description générale

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.

Actions biochimiques/physiologiques

La L-glutamine est un acide aminé essentiel qui sert d′importante source d′énergie aux cellules en culture et constitue un composant crucial des milieux de culture. La L-glutamine est très stable sous forme de poudre sèche ou de solution congelée. Elle se dégrade toutefois assez rapidement dans les milieux liquides et les solutions mères. L′atteinte de performances cellulaires optimales nécessite généralement l′ajout d′un supplément en L-glutamine au milieu avant utilisation.

Remarque sur l'analyse

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

Informations légales

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

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

Informations sur la sécurité

• Code de la classe de stockage: 13 - Non Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 1
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable