推荐产品
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
应用
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.
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.
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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