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Key Documents

Safety Information

1.08694

SAFC

Deviron® 13-S9

Detergent, EMPROVE® EXPERT

Pharma Manufacturing

Synonym(s):

Alcohols, C11-15-secondary, ethoxylated

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About This Item

Empirical Formula (Hill Notation):
CH3(CH2)nCH(CH2)mCH3O(CH2CH2O)xH
UNSPSC Code:
12352200

Quality Level

product line

EMPROVE® EXPERT

application(s)

pharma/biopharma processes

storage temp.

15-25°C

General description

Detergents, such as non-ionic surfactants, are used in biomanufacturing processes for a variety of applications including viral inactivation and cell lysis. Detergent-mediated viral inactivation is widely used in multiple biotherapeutic production processes to ensure meeting regulatory requirements for viral safety.

Our SAFC portfolio of high-quality raw materials for use in biopharmaceutical processing withstands strict quality control procedures plus the documentation and expertise to help our customers meet requirements as defined by the M-Clarity Program.

M-Clarity Program

As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.

Our comprehensive portfolio of downstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Ranging from non-GMP grades for low-risk application, to IPEC-PQG GMP for higher-risk applications, we have products covering all your manufacturing needs.

We offer a range of high quality critical raw materials plus the documentation and expertise to help our customers meet stringent regulatory requirements. Our SAFC portfolio of high-quality products withstands strict quality control procedures.

Application

REACH compliantdetergent used in viral inactivation or cell lysis.

Packaging

1.08694.1000 / 1L / Glass bottle

1.08694.2500 / 2.5L / Glass bottle

1.08694.9025 / 25L / PE container

Legal Information

DEVIRON is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Pictograms

CorrosionExclamation mark

Signal Word

Danger

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 3 - Eye Dam. 1 - Skin Irrit. 2

Storage Class Code

10 - Combustible liquids

WGK

WGK 1

Flash Point(F)

469.4 °F - open cup

Flash Point(C)

243 °C - open cup


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

FSL

Flammable liquids
Type 4 petroleums
Hazardous rank III

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names


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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