1.00286

L-Glutamine

EMPROVE^® EXPERT, DAB, JP, USP

• Synonim(y): L-Glutamic acid-5-amide, Gln, (S)-2,5-Diamino-5-oxopentanoic acid, L-Glutamic acid 5-amide, Levoglutamide
• Wzór liniowy: H₂NCOCH₂CH₂CH(NH₂)CO₂H
• Numer CAS: 56-85-9
• Masa cząsteczkowa: 146.14
• Beilstein: 1723797
• Numer MDL: MFCD00008044
• Kod UNSPSC: 12352209
• Numer indeksu EC: 200-292-1

Właściwości

• agency: DAB; JP; USP
• Poziom jakości: 500
• opis: EMPROVE^® EXPERT DAB,USP
• linia produktu: EMPROVE^® EXPERT
• Postać: solid
• siła działania: 7500 mg/kg LD₅₀, oral (Rat)
• metody: API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 4.0-6.0 (20 °C, 25 g/L in H₂O)
• mp: 185 °C (dec.) (lit.)
• rozpuszczalność: 100 g/L
• gęstość: 1.47 g/cm³ at 20 °C
• gęstość nasypowa: 640 kg/m³
• temp. przechowywania: 2-30°C
• ciąg 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
• Klucz InChI: ZDXPYRJPNDTMRX-VKHMYHEASA-N

Opis

Opis ogólny

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.

Działania biochem./fizjol.

L-Glutamine is an essential amino acid that is a crucial component of culture media that serves as a major energy source for cells in culture. L-Glutamine is very stable as a dry powder and as a frozen solution. In liquid media or stock solutions, however, L-glutamine degrades relatively rapidly. Optimal cell performance usually requires supplementation of the media with L-glutamine prior to use.

Komentarz do analizy

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

Informacje prawne

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

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

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Informacja o środkach bezpieczeństwa

• Kod klasy składowania: 13 - Non Combustible Solids
• Klasa zagrożenia wodnego (WGK): WGK 1
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable