Merck
All Photos(1)

1.37171

SAFC

Polysorbate 80

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

Synonym(s):
POE (20) sorbitan monooleate, Polyoxyethylenesorbitan monooleate, Polyethylene glycol sorbitan monooleate, TWEEN 80, Polysorbate 80
CAS Number:
Número MDL:
Número índice de la CE:
500-019-9

Nivel de calidad

500

origen biológico

synthetic

grado

GDP
GMP
Halal
Kosher

Agency

ChP
JP
NF
Ph. Eur.

descripción

GMO free
low in endotoxins

línea de producto

EMPROVE® EXPERT

formulario

liquid

potencia

42200 mg/kg LD50, oral

mol peso

1310 g/mol

pH

5-7 (20 °C, 50 g/L)

bp

>100 °C

densidad

1.07 g/cm3 at 25 °C

application(s)

liquid formulation
parenterals
pharmaceutical

actividad extraña

Aflatoxin free

temp. de almacenamiento

15-25°C

InChI

1S/C32H60O10/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-30(36)40-25-24-37-27-29(39-22-19-34)32-28(38-21-18-33)26-31(42-32)41-23-20-35/h9-10,28-29,31-35H,2-8,11-27H2,1H3/b10-9+

InChI key

RGPBUVUVZKQNHD-MDZDMXLPSA-N

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Descripción general

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
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

Polysorbate 80 is used to stabilize biomolecule formulations and as solubilizer, emulsifier and wetting agent in small molecule formulations.
Polysorbates are known to degrade via autoxidation and hydrolysis. Degradation products can have a negative impact on the stability of the protein as well as the small molecule API. To reduce this risk, the polysorbate high-purity grade contains a low amount of impurities, especially peroxides.
In addition, the product is protected from oxidation by the packaging system. The bottle contains a nitrogen overlay. A special lid allows removal of the content with a syringe without opening the bottle. Intended for high-risk applications, this Emprove® Expert grade contains bioburden and endotoxin limits.

Envase

1371710100 / 100ml / glass bottle
1371711000 / 1L / glass bottle

Información legal

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
TWEEN is a registered trademark of Croda International PLC

Código de clase de almacenamiento

10 - Combustible liquids

WGK

WGK 1

Punto de inflamabilidad F

235.4 °F - closed cup

Punto de inflamabilidad C

> 113 °C - closed cup

Certificate of Analysis

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Certificate of Quality

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What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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