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1.37171

Polysorbate 80

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

Synonym(s):

TWEEN® 80, POE (20) sorbitan monooleate, Polyethylene glycol sorbitan monooleate, Polyoxyethylenesorbitan monooleate, Polysorbate 80

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About This Item

CAS Number:
9005-65-6
UNSPSC Code:
12352207
EC Index Number:
500-019-9
MDL number:
MFCD00082107
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biological source

synthetic

Quality Level

500

grade

GMP, Halal, Kosher

agency

NF, ChP, JP, 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
pharmaceutical
solubility enhancement

foreign activity

Aflatoxin free

storage temp.

15-25°C

SMILES string

CCCCCCCC/C=C/CCCCCCCC(=O)OCCOCC(C1C(CC(O1)OCCO)OCCO)OCCO

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

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
TWEEN is a registered trademark of Croda International PLC

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Storage Class

10 - Combustible liquids

wgk

WGK 1

flash_point_c

> 113 °C - closed cup

flash_point_f

>235.4 °F - closed cup

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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