1.37171

Polysorbate 80

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

• Synonym(s): Polysorbate 80, POE (20) sorbitan monooleate, Polyethylene glycol sorbitan monooleate, Polyoxyethylenesorbitan monooleate
• CAS Number: 9005-65-6
• MDL number: MFCD00082107
• EC Index Number: 500-019-9

Properties

• biological source: synthetic
• Quality Level: 500
• grade: GDP; GMP; Halal; Kosher
• Agency: ChP; JP; NF; Ph. Eur.
• description: GMO free; low in endotoxins
• product line: EMPROVE^® EXPERT
• form: liquid
• potency: 42200 mg/kg LD₅₀, oral
• mol wt: 1310 g/mol
• pH: 5-7 (20 °C, 50 g/L)
• bp: >100 °C
• density: 1.07 g/cm³ at 25 °C
• application(s): liquid formulation; parenterals; pharmaceutical
• foreign activity: Aflatoxin free
• storage temp.: 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

Description

General description

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 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.

Packaging

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

Legal Information

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

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

Safety Information

• Storage Class Code: 10 - Combustible liquids
• WGK: WGK 1
• Flash Point(F): 235.4 °F - closed cup
• Flash Point(C): > 113 °C - closed cup