1.04090

Glutathione (reduced) EMPROVE^® EXPERT Ph Eur

suitable for biopharmaceutical production EMPROVE^® bio Ph Eur

• Synonim(y): Glutathione (reduced), γ-L-Glutamyl-L-cysteinglycine, GSH
• Wzór empiryczny (zapis Hilla): C₁₀H₁₇N₃O₆S
• Numer CAS: 70-18-8
• Masa cząsteczkowa: 307.32
• UNSPSC Code: 12352209
• EC Index Number: 200-725-4
• MDL number: MFCD00065939

Właściwości

• agency: Ph. Eur.
• Quality Segment: 500
• product line: EMPROVE^® EXPERT
• pH: 3 (20 °C, 10 g/L in H₂O)
• mp: 185-195 °C
• solubility: 100 g/L
• bulk density: 160 kg/m³
• application(s): pharma/biopharma processes
• storage temp.: 2-8°C
• SMILES string: SCC(NC(=O)CCC([N+H3])C(=O)[O-])C(=O)NCC(=O)O
• InChI: 1S/C10H17N3O6S/c11-5(10(18)19)1-2-7(14)13-6(4-20)9(17)12-3-8(15)16/h5-6,20H,1-4,11H2,(H,12,17)(H,13,14)(H,15,16)(H,18,19)
• InChI key: RWSXRVCMGQZWBV-UHFFFAOYSA-N

Opis

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 downstream 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. Ranging from non-GMP grades for low-risk application, to IPEC-PQG GMP for higher-risk applications, we have products covering all your manufacturing needs.

Application

Glutathione (reduced) is essential in biopharmaceutical manufacturing, serving as a powerful antioxidant that protects cells and proteins from oxidative damage. It maintains a favorable redox environment, enhancing protein folding and stability, which is vital for the efficacy of therapeutic proteins. Additionally, glutathione (reduced) supports cellular health and viability in mammalian cell cultures, leading to improved yields and productivity in the production of biologics. Overall, it plays a critical role in ensuring the integrity and quality of final pharmaceutical products.

Analysis Note

Assay (iodometric, calc. on dried substance): 98.0 - 101.0 %
Identity (IR-spectrum): passes test
Appearance: white to almost white, slightly agglomerated, crystalline powder
Appearance of solution (100 g/l, water): clear and colorless.
Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance): -15.5° to -17.5°
Chloride (Cl): ≤ 200 ppm
Sulfate (SO₄): ≤ 300 ppm
As (Arsenic): ≤ 1.5 ppm
Fe (Iron): ≤ 10 ppm
Fe (Iron) (ICP): ≤ 10 ppm
NH₄ (Ammonium): ≤ 200 ppm
Cu (Copper)*: ≤ 25 ppm
Related substances (CE) (Impurity A (Cysteinylglycine)): ≤ 0.5 %
Related substances (CE) (Impurity B (Cysteine)): ≤ 0.5 %
Related substances (CE) (Impurity C (Glutathione oxidized)): ≤ 1.5 %
Related substances (CE) (Impurity D (Glutamylcysteine)): ≤ 1.0 %
Related substances (CE) (Impurity E): ≤ 0.5 %
Related substances (CE) (Largest unspecified impurity): ≤ 0.2 %
Related substances (CE) (Sum of all impurities): ≤ 2.5 %
Acetic acid (HS-GC): ≤ 5000 ppm
Ethanol (HS-GC): ≤ 5000 ppm
Ethyl acetate (HS-GC): ≤ 5000 ppm
Other residual solvents (ICH Q3C): passes test
Sulfated ash (600 °C): ≤ 0.1 %
Loss on drying (105 °C; 3 h): ≤ 0.5 %
Elemental 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.

Legal Information

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

• Klasa składowania: 11 - Combustible Solids
• wgk: WGK 2
• flash_point_f: Not applicable
• flash_point_c: Not applicable