1.00286

L-glutammina

EMPROVE^® EXPERT, DAB, JP, USP

• Sinonimo/i: 5-ammide dell’acido L-glutammico, Acido (S)-2,5-diammino-5-ossopentanoico, Levoglutamide
• Formula condensata: H₂NCOCH₂CH₂CH(NH₂)CO₂H
• Numero CAS: 56-85-9
• Peso molecolare: 146.14
• UNSPSC Code: 12352209
• EC Index Number: 200-292-1
• Beilstein/REAXYS Number: 1723797

Proprietà

• Quality Segment: 500
• agency: DAB, JP, USP
• description: EMPROVE^® EXPERT DAB,USP
• product line: EMPROVE^® EXPERT
• form: solid
• potency: 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)
• mp: 185 °C (dec.) (lit.)
• solubility: 100 g/L
• density: 1.47 g/cm³ at 20 °C
• bulk density: 640 kg/m³
• storage temp.: 2-30°C

Descrizione

General description

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.

Biochem/physiol Actions

La L-glutammina è un amminoacido essenziale oltre che un componente fondamentale dei terreni di coltura e costituisce un′importante fonte di energia per le cellule coltivate. La L-glutammina è molto stabile in forma di polvere secca e di soluzione congelata. Tuttavia, nei terreni liquidi e nelle soluzioni madri, la L-glutammina si degrada con relativa rapidità. Per una resa ottimale delle cellule è generalmente necessaria l′integrazione dei terreni di coltura con la L-glutammina prima dell′uso.

Analysis Note

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

Legal Information

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

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

Informazioni sulla sicurezza

• Classe di stoccaggio: 13 - Non Combustible Solids
• wgk: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable