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Merck

1.03789

SAFC

Sacarosa

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

Fabricación farmacéutica

Sinónimos:

α-D-Glc-(1→2)-β-D-Fru, α-D-Glucopiranosil β-D-fructofuranósido, ββ-D-Fructofuranosil-α-D-glucopiranósido, D(+)-Sacarosa, Azúcar

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About This Item

Fórmula empírica (notación de Hill):
C12H22O11
Número de CAS:
Peso molecular:
342.30
Beilstein:
90825
Número MDL:
Código UNSPSC:
12352201
En este momento no podemos mostrarle ni los precios ni la disponibilidad

Agency

ChP
JP
NF
Ph. Eur.

Nivel de calidad

Línea del producto

EMPROVE® EXPERT

Formulario

solid

Características

RNase and DNase free

impurezas

≤0.3 IU/g endotoxin (low)

pH

7 (20 °C, 100 g/L in H2O)

mp

185-187 °C (lit.)

aplicaciones

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

Condiciones de envío

ambient

temp. de almacenamiento

2-30°C

cadena 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

Clave InChI

CZMRCDWAGMRECN-UGDNZRGBSA-N

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Descripción general

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.

Aplicación

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.

Información legal

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

Aplicación

Referencia del producto
Descripción
Precios

Producto relacionado

Referencia del producto
Descripción
Precios

Código de clase de almacenamiento

11 - Combustible Solids

Clase de riesgo para el agua (WGK)

WGK 1

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable


¿Qué es el programa Emprove®?

El programa Emprove® es un sistema que proporciona documentación completa y exhaustiva de nuestros filtros y componentes de un solo uso, materias primas farmacéuticas y materiales de partida.

Material Qualification Dossier

Gratuito, iniciar sesión para descargar

Quality Management Dossier (Open Access)

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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Disponible mediante suscripción o mediante pago de una tarifa.

Operational Excellence Dossier

Disponible mediante suscripción o mediante pago de una tarifa.

Más información sobre las ventajas que le puede proporcionar una suscripción al programa Emprove®
¿Por qué no están disponibles estos documentos?
Los expedientes Emprove® contienen información destinada a respaldar el proceso de registro y las actividades de evaluación del riesgo de los productores farmacéuticos y contienen información confidencial. contacte con nosotros si desea tener acceso.

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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

Artículos

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

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

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

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.

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

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

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

Contenido relacionado

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

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

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