Merck

1.04090

SAFC

谷胱甘肽(还原型)

suitable for biopharmaceutical production EMPROVE® bio Ph Eur

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别名:
Glutathione (reduced), γ-L-Glutamyl-L-cysteinglycine, GSH
经验公式(希尔记法):
C10H17N3O6S
CAS号:
分子量:
307.32
MDL编号:
EC索引号:
200-725-4

Agency

Ph. Eur.

质量水平

产品线

EMPROVE® Bio

pH值(酸碱度)

3 (20 °C, 10 g/L in H2O)

mp

185-195 °C

溶解性

100 g/L

堆积密度

160 kg/m3

application(s)

parenterals
parenterals

储存温度

2-8°C

InChI

1S/C10H17N3O6S/c11-5(10(18)19)1-2-7(14)13-6(4-20)9(17)12-3-8(15)16/h5-6,20H,1-4,11H2,(H,12,17)(H,13,14)(H,15,16)(H,18,19)

InChI key

RWSXRVCMGQZWBV-UHFFFAOYSA-N

一般描述

Our SAFC® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.

M-Clarity Program

As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.

Our comprehensive portfolio of downstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Ranging from non-GMP grades for low-risk application, to IPEC-PQG GMP for higher-risk applications, we have products covering all your manufacturing needs.

分析说明

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 %
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.

法律信息

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

储存分类代码

11 - Combustible Solids

WGK

WGK 2

闪点(°F)

Not applicable

闪点(°C)

Not applicable


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