1.37172

Polysorbate 20

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

• Synonyme(s) : Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20
• Numéro CAS: 9005-64-5
• Numéro MDL: MFCD00165986
• Code UNSPSC : 12161900
• Numéro de classement CE : 500-018-3

Propriétés

• Source biologique: synthetic
• Niveau de qualité: 500
• 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

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

Informations sur la sécurité

• 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