1.37172
Polysorbate 20
high purity, EMPROVE® EXPERT, Ph. Eur., ChP, JPE, NF
Pharma Manufacturing
Synonym(s):
Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20
About This Item
Recommended Products
biological source
synthetic
Quality Level
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
General description
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
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
1.371721000 / 1l / glass bottle
Legal Information
Application
related product
Storage Class
10 - Combustible liquids
wgk_germany
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’.
Already Own This Product?
Find documentation for the products that you have recently purchased in the Document Library.
Articles
This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.
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.
Related Content
Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.
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.
Contact Technical Service