Glutathione (Reduced) 5G

Description

Catalogue Number	104090
Synonyms	γ-L-Glutamyl-L-cysteinglycine, GSH

Product Information

CAS number	70-18-8
EC number	200-725-4
Grade	Ph Eur
Hill Formula	C₁₀H₁₇N₃O₆S
Molar Mass	307.32 g/mol
HS Code	2930 90 98

Physicochemical Information

Melting Point	185 - 195 °C
pH value	3 (10 g/l, H₂O, 20 °C)
Bulk density	160 kg/m3
Solubility	100 g/l

Storage and Shipping Information

Storage

Store at +2°C to +8°C.

Specifications

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
Sulphate (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.