Pular para o conteúdo
Merck

1.03789

SAFC

Sacarose

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

Fabricação farmacêutica

Sinônimo(s):

α α-D-Glc-(1→2)-β-D-Fru, α α-D-glicopiranosil β-D-frutofuranosídeo, ββ-D-frutofuranosil-α-D-glicopiranosídeo, D(+)-sacarose, Açúcar

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About This Item

Fórmula empírica (Notação de Hill):
C12H22O11
Número CAS:
Peso molecular:
342.30
Beilstein:
90825
Número MDL:
Código UNSPSC:
12352201

Agency

ChP
JP
NF
Ph. Eur.

Nível de qualidade

linha de produto

EMPROVE® EXPERT

forma

solid

Características

RNase and DNase free

Impurezas

≤0.3 IU/g endotoxin (low)

pH

7 (20 °C, 100 g/L in H2O)

pf

185-187 °C (lit.)

aplicação(ões)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

Condições de expedição

ambient

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

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

chave InChI

CZMRCDWAGMRECN-UGDNZRGBSA-N

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Descrição geral

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.

Aplicação

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.

Informações legais

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

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 1

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


Certificados de análise (COA)

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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

Artigos

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

Protocolos

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

Conteúdo relacionado

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

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