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Merck

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:
分子量:
342.30
Beilstein:
90825
MDL號碼:
分類程式碼代碼:
12352201

agency

ChP
JP
NF
Ph. Eur.

品質等級

產品線

EMPROVE® EXPERT

形狀

solid

特點

RNase and DNase free

雜質

≤0.3 IU/g endotoxin (low)

pH值

7 (20 °C, 100 g/L in H2O)

mp

185-187 °C (lit.)

應用

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

運輸包裝

ambient

儲存溫度

2-30°C

SMILES 字串

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 密鑰

CZMRCDWAGMRECN-UGDNZRGBSA-N

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一般說明

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.

應用

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.

法律資訊

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

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 1

閃點(°F)

Not applicable

閃點(°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

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

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

相关内容

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

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