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Merck

1.37172

Polysorbate 20

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

동의어(들):

Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20

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제품정보 (DICE 배송 시 비용 별도)

CAS 번호:
UNSPSC Code:
12161900
EC Index Number:
500-018-3
MDL number:
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biological source

synthetic

Quality Level

grade

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

SMILES string

O1C(C(C(C1)OCCO)OCCO)C(OCCO)COCCOC(=O)CCCCCCCCCCC

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

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


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저장 등급

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



시험 성적서(COA)

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문서 라이브러리 방문


문서

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.

This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.

관련 콘텐츠

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.

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.

Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.





국제 무역 품목 번호

SKUGTIN
137172100004065265252720
137172010004065265252607