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1.37172

SAFC

Polysorbate 20

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

Fabrication pharma

Synonyme(s) :

Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20

Se connecterpour consulter vos tarifs contractuels et ceux de votre entreprise/organisme


About This Item

Numéro CAS:
Numéro MDL:
Code UNSPSC :
12161900
Numéro de classement CE :
500-018-3

Source biologique

synthetic

Niveau de qualité

Qualité

GDP
GMP
Halal
Kosher

Agence

ChP
JPE
NF
Ph. Eur.

Description

GMO free
low in endotoxins

Gamme de produits

EMPROVE® EXPERT

Forme

liquid

Puissance

38900 mg/kg LD50, oral

Poids mol.

1228 g/mol

pH

6-8 (20 °C, 50 g/L, H2O)

Point d'ébullition

>100 °C

Pf

98.9 °C

Densité

1.1 g/cm3 at 25 °C

Application(s)

liquid formulation
parenterals
pharmaceutical

Activité étrangère

Aflatoxin free

Température de stockage

15-25°C

InChI

1S/C26H50O10/c1-2-3-4-5-6-7-8-9-10-11-24(30)34-19-18-31-20-22(32-15-12-27)26-25(35-17-14-29)23(21-36-26)33-16-13-28/h22-23,25-29H,2-21H2,1H3

Clé InChI

HMFKFHLTUCJZJO-UHFFFAOYSA-N

Description générale

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.

Application

Polysorbate 20 is used to stabilize biomolecule formulations and as solubilizer, emulsifier and wetting agent in small molecule formulation.


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.


Intended for high-risk applications, this Emprove® Expert grade contains bioburden and endotoxin limits.

Conditionnement

1.371720100 / 100ml / glass bottle
1.371721000 / 1l / glass bottle

Informations légales

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

Code de la classe de stockage

10 - Combustible liquids

Classe de danger pour l'eau (WGK)

WGK 1

Point d'éclair (°F)

527.0 °F - Pensky-Martens closed cup

Point d'éclair (°C)

275 °C - Pensky-Martens closed cup


Certificats d'analyse (COA)

Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".

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Articles

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.

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Contenu apparenté

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.

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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