L(-)-Glutathione (reduced form) 98.0-101.0% (by iodometry), EMPROVE® EXPERT Ph. Eur. for biopharmaceutical production

Supplier: MilliporeSigma

Synonyms: L-Glutathione ReducedGlutathione Reduced(S)-2-Amino-5-(((R)-1-((carboxymethyl)amino)-3-mercapto-1-oxopropan-2-yl)amino)-5-oxopentanoic acidGSH

1.04090.0050 1.04090.0005 1.04090.0500
EM1.04090.0500EA 6733.11 USD
EM1.04090.0500 EM1.04090.0050 CA1.04090.0005
L(-)-Glutathione (reduced form) 98.0-101.0% (by iodometry), EMPROVE® EXPERT Ph. Eur. for biopharmaceutical production
L(-)-Glutathione (reduced 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 (*).

Formula: C₁₀H₁₇N₃O₆S
MW: 307.33 g/mol
Melting Pt: 185…195 °C
Density: 160 kg/m³
Storage Temperature: Refrigerator
MDL Number: MFCD00065939
CAS Number: 70-18-8

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Specification Test Results

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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