Glutathion (reduziert) 98,0-101,0% (durch Iodometrie), EMPROVE® EXPERT Ph. Eur. für die biopharmazeutische Produktion, SAFC®

Lieferant: Merck

Synonyme: L(-)-Glutathion, reduziertγ-L-Glutamyl-L-cysteinylglycinGSH

1.04090.0050EA 447 EUR
1.04090.0050 MERP1.04090.9999 1.04090.0500 1.04090.0005
Glutathion (reduziert) 98,0-101,0% (durch Iodometrie), EMPROVE® EXPERT Ph. Eur. für die biopharmazeutische Produktion, SAFC®
L(-)-Glutathion (reduzierte Form)

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 (*).

Formel: C₁₀H₁₇N₃O₆S
Molecular Weight: 307,33 g/mol
Schmelzpunkt: 185…195 °C
Dichte: 1,475 g/cm³ (20 °C)
Lagertemperatur: Kühlschrank
MDL: MFCD00065939
CAS-Nummer: 70-18-8
EINECS: 200-725-4
Merck Index: 13,04488

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Spezifikation Testergebnisse

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 %
Corresponds to Ph. Eur.

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