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1.37172

SAFC

Polysorbate 20

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

Pharma Manufacturing

Synonym(s):

Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20

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About This Item

CAS Number:
9005-64-5
MDL number:
MFCD00165986
UNSPSC Code:
12161900
EC Index Number:
500-018-3

biological source

synthetic

Quality Level

500

grade

GDP
GMP
Halal
Kosher

Agency

ChP
JPE
NF
Ph. Eur.

description

GMO free
low in endotoxins

product line

EMPROVE® EXPERT

form

liquid

potency

38900 mg/kg LD50, oral

mol wt

1228 g/mol

pH

6-8 (20 °C, 50 g/L, H2O)

bp

>100 °C

mp

98.9 °C

density

1.1 g/cm3 at 25 °C

application(s)

liquid formulation
parenterals
pharmaceutical

foreign activity

Aflatoxin free

storage temp.

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

InChI key

HMFKFHLTUCJZJO-UHFFFAOYSA-N

Related Categories

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 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.

Packaging

1.371720100 / 100ml / glass bottle
1.371721000 / 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 Code

10 - Combustible liquids

WGK

WGK 1

Flash Point(F)

527.0 °F - Pensky-Martens closed cup

Flash Point(C)

275 °C - Pensky-Martens 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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