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

Supplier: MilliporeSigma

Certificates

Supplier: MilliporeSigma

Certificates

About this item

CAS Number:70-18-8

Formula:C₁₀H₁₇N₃O₆S

MDL Number:MFCD00065939

:307.33 g/mol

Melting Pt:185…195 °C

Density:160 kg/m³

Storage Temperature:Refrigerator

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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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