L(-)-Glutathione (reduced form) 98.0-101.0% (by iodometry), EMPROVE® EXPERT Ph. Eur. for biopharmaceutical production
Supplier: MilliporeSigma
Synonyms:
L-Glutathione Reduced
, Glutathione Reduced
, (S)-2-Amino-5-(((R)-1-((carboxymethyl)amino)-3-mercapto-1-oxopropan-2-yl)amino)-5-oxopentanoic acid
, GSH
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 |
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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