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1.37172

SAFC

Polysorbate 20

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

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Synonym(s):
Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20
CAS Number:
9005-64-5
MDL number:
MFCD00165986
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

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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 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

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

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Articles

Strategies for the Development of Safe and Effective Pediatric Formulations

Medicine for children poses unique formulation challenges compared to adults. Consider developmental physiology and age specifics when designing pharmaceuticals. Quality issues can severely impact patient safety. Therefore, excipient quality, supplier selection, and supply chain security are crucial, particularly for pediatric formulations.

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Pediatric Formulations

Developing formulations specifically for infants and children is increasingly important. To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and APIs for pediatric pharmaceutical formulations that are proven in practice.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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