L(-)-Glutatione (forma ridotta) 98.0-101.0% (by iodometry), EMPROVE® EXPERT Ph. Eur. per la produzione biofarmaceutica, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
Synonyms:
L-Glutathione Reduced, GSH, (S)-2-Amino-5-(((R)-1-((carboxymethyl)amino)-3-mercapto-1-oxopropan-2-yl)amino)-5-oxopentanoic acid, Glutathione Reduced
1.04090.0005
1.04090.0050
1.04090.0500
1.04090.0005EA
59.2
EUR
1.04090.0005
1.04090.0050
1.04090.0500
L(-)-Glutatione (forma ridotta) 98.0-101.0% (by iodometry), EMPROVE® EXPERT Ph. Eur. per la produzione biofarmaceutica, SAFC®
L(-)-Glutatione (forma ridotta)
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 Peso molecolare: 307,33 g/mol Punto di fusione: 185…195 °C Densità: 1,475 g/cm³ (20 °C) Temperatura di stoccaggio: Refrigerata |
MDL Number:
MFCD00065939 CAS Number: 70-18-8 EINECS: 200-725-4 Merck Index: 13,04488 |
Risultati del test di specificazione
| 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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