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Safety Information

1.42022

SAFC

Sulfobutylether-β-Cyclodextrin sodium salt

new

EMPROVE® EXPERT, Ph. Eur., NF

Pharma Manufacturing

Synonym(s):

Betadex Sulfobutyl ether sodium; SBEBCD; SBE-β-CD, Sulfobutylether-β-Cyclodextrin sodium salt EMPROVE EXPERT Ph Eur,NF

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About This Item

Agency

NF
Ph. Eur.

Quality Level

500

product line

EMPROVE® EXPERT

form

powder

application(s)

liquid formulation
parenterals
solubility enhancement

storage temp.

15-25°C

General description

When working on a pharmaceutical formulation, there are specific considerations to make and challenging hurdles to take before you can successfully launch your final drug product - formulation stability, release kinetics and bioavailability limitations just to name a few. 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

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.

Legal Information

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

related product

Product No.
Description
Pricing

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H317

Hazard Classifications

Skin Sens. 1

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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.

JAN Code

1420222500BWT:
1420222500:
1420220050BWT:
1420220050:
1420220000:

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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