Skip to Content

Key Documents

View All Documentation

1.37171

Polysorbate 80

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

Synonym(s):

POE (20) sorbitan monooleate, Polyethylene glycol sorbitan monooleate, Polyoxyethylenesorbitan monooleate

Sign In to View Organizational & Contract Pricing.

Select a Size

Change View

About This Item

UNSPSC Code:
12352207
EC Index Number:
500-019-9
Technical Service
Need help? Our team of experienced scientists is here for you.
Let Us Assist

biological source

synthetic

Quality Segment

500

grade

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

impurities

endotoxins, low

pH

5-7 (20 °C, 50 g/L)

bp

>100 °C

density

1.07 g/cm3 at 25 °C

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
solubility enhancement
viral inactivation

foreign activity

Aflatoxin free

storage temp.

15-25°C

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 peroxide.

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

Storage Class

10 - Combustible liquids

wgk

WGK 1

flash_point_c

> 113 °C - closed cup

flash_point_f

>235.4 °F - closed cup

Stay compliant with GMP using the Emprove® Program

Accelerate qualification, maintain compliance, and save time with Emprove® Dossiers.

Download Dossiers

Note: you will be brought to EmproveSuite.com. Your username and password are separate from SigmaAldrich.com and may differ.

Register for free and access Emprove® Dossiers within minutes. Upgrade your subscription plan to unlock advanced and customized content in the Emprove® Suite

Not finding what you are looking for? Visit the Emprove® Program Help page.

Already Own This Product?

Find documentation for the products that you have recently purchased in the Document Library.

Visit the Document Library

Difficulty Finding Your Product Or Lot/Batch Number?

Product numbers are combined with Pack Sizes/Quantity when displayed on the website (example: T1503-25G). Please make sure you enter ONLY the product number in the Product Number field (example: T1503).

Example:

T1503
Product Number
-
25G
Pack Size/Quantity

Additional examples:

705578-5MG-PW

PL860-CGA/SHF-1EA

MMYOMAG-74K-13

1000309185

enter as 1.000309185)

Having trouble? Feel free to contact Technical Service for assistance.