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Merck
CN
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文件

安全信息

1.03789

SAFC

蔗糖

EMPROVE® EXPERT, Ph. Eur., ChP, JP, NF

制药生产

别名:

α-D-Glc-(1→2)-β-D-Fru, α-D-吡喃葡萄糖基β-D-呋喃果糖苷, β-D-果糖-α-D-吡喃葡萄糖苷, D(+)-蔗糖, 糖

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About This Item

经验公式（希尔记法）:
C12H22O11
CAS号:
57-50-1
分子量:
342.30
Beilstein:
90825
MDL编号:
MFCD00006626
UNSPSC代码:
12352201

Agency

ChP
JP
NF
Ph. Eur.

质量水平

500

产品线

EMPROVE® EXPERT

形式

solid

特点

RNase and DNase free

杂质

≤0.3 IU/g endotoxin (low)

pH值（酸碱度）

7 (20 °C, 100 g/L in H2O)

mp

185-187 °C (lit.)

应用

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

运输

ambient

储存温度

2-30°C

SMILES字符串

OC[C@H]1O[C@H](O[C@]2(CO)O[C@H](CO)[C@@H](O)[C@@H]2O)[C@H](O)[C@@H](O)[C@@H]1O

InChI

1S/C12H22O11/c13-1-4-6(16)8(18)9(19)11(21-4)23-12(3-15)10(20)7(17)5(2-14)22-12/h4-11,13-20H,1-3H2/t4-,5-,6-,7-,8+,9-,10+,11-,12+/m1/s1

InChI key

CZMRCDWAGMRECN-UGDNZRGBSA-N

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一般描述

Chemicals play an important role in the stabilization of a biologic drug during its manufacturing and formulation process – for instance, by preventing aggregation. We offer a wide range of high-quality stabilizers, buffers and salts to successfully purify and formulate your biomolecules. Specifically developed for high-risk applications, they are low in bioburden and endotoxins.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

应用

Sucrose is used as a stabilizer for the formulation of biomolecules.
We have developed a new filtration-based manufacturing process leading to a sucrose grade with unique quality characteristics: Sucrose Emprove® Expert Ph Eur, ChP, JP, NF is low in endotoxins and has extensively reduced levels of nanoparticulate impurities which can negatively influence the stability of biomolecule formulations, making it the ideal choice for your high-risk applications.

法律信息

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

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WGK

WGK 1

闪点(°F)

Not applicable

闪点(°C)

Not applicable

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Daniel Weinbuch et al.
Pharmaceutical research, 34(12), 2910-2921 (2017-10-27)
To investigate the effect of nanoparticulate impurities (NPIs) isolated from pharmaceutical-grade sucrose, on the stability of monoclonal antibodies (mAbs). NPIs were purified from pharmaceutical-grade sucrose and spiked into trastuzumab, rituximab, infliximab, and cetuximab formulations. The stability of the mAbs as
Daniel Weinbuch et al.
Pharmaceutical research, 32(7), 2419-2427 (2015-01-30)
In the present study we investigated the root-cause of an interference signal (100-200 nm) of sugar-containing solutions in dynamic light scattering (DLS) and nanoparticle tracking analysis (NTA) and its consequences for the analysis of particles in biopharmaceutical drug products. Different

商品

Use of Stabilizers and Surfactants to Prevent Protein Aggregation

This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.

实验方案

Low NPI Sucrose for Biopharmaceutical Formulations

This article describes a purification process resulting in low nanoparticulate impurities sucrose, enabling more stable protein formulations.

相关内容

Formulation

Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.

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