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Merck
모든 사진(1)

주요 문서

1.37172

SAFC

Polysorbate 20

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

의약품 제조

동의어(들):

Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20

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About This Item

CAS Number:
MDL number:
UNSPSC 코드:
12161900
EC 인덱스 번호:
500-018-3

생물학적 소스

synthetic

Quality Level

Grade

GDP
GMP
Halal
Kosher

Agency

ChP
JPE
NF
Ph. Eur.

설명

GMO free
low in endotoxins

제품 라인

EMPROVE® EXPERT

형태

liquid

효능

38900 mg/kg LD50, oral

분자량

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

응용 분야

liquid formulation
parenterals
pharmaceutical

외래 활성

Aflatoxin free

저장 온도

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

일반 설명

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.

애플리케이션

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.

포장

1.371720100 / 100ml / glass bottle
1.371721000 / 1l / glass bottle

법적 정보

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


시험 성적서(COA)

제품의 로트/배치 번호를 입력하여 시험 성적서(COA)을 검색하십시오. 로트 및 배치 번호는 제품 라벨에 있는 ‘로트’ 또는 ‘배치’라는 용어 뒤에서 찾을 수 있습니다.

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문서 라이브러리 방문

문서

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.

관련 콘텐츠

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.

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.

자사의 과학자팀은 생명 과학, 재료 과학, 화학 합성, 크로마토그래피, 분석 및 기타 많은 영역을 포함한 모든 과학 분야에 경험이 있습니다..

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