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1.03789

スクロース

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

別名:

α-D-Glc-(1→2)-β-D-Fru, α-D-グルコピラノシルβ-D-フルクトフラノシド, β-D-フルクトフラノシル-α-D-グルコピラノシド, D(+)-サッカロース, 砂糖

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この商品について

実験式（ヒル表記法）:
C12H22O11
CAS番号:
57-50-1
分子量:
342.30
UNSPSC Code:
12352201
Beilstein/REAXYS Number:
90825
MDL number:
MFCD00006626
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Quality Level

500

agency

ChP, JP, NF, Ph. Eur.

product line

EMPROVE® EXPERT

form

solid

feature

RNase and DNase free

impurities

≤0.3 IU/g endotoxin (low)

pH

7 (20 °C, 100 g/L in H2O)

mp

185-187 °C (lit.)

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

shipped in

ambient

storage temp.

2-30°C

SMILES string

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

General description

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.

Application

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.

Legal Information

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

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保管分類

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

試験成績書（COA）

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プロトコル

Low NPI Sucrose for Biopharmaceutical Formulations

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

資料

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.

関連コンテンツ

Formulation

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

Stabilizer Flyer
Protecting Protein Stability with a Novel Grade of Sucrose
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

グローバルトレードアイテム番号

カタログ番号GTIN
1.03789.902504054839595486
1.03789.100004054839593604
1.03789.901204054839595363