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SAFC

Sulfobutylether-β-Cyclodextrin sodium salt

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

UNSPSC Code:
12352200
Pricing and availability is not currently available.

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

Sulfobutylether-β-Cyclodextrin Sodium Salt is a Cyclodextrin derivate with very high solubilization characteristics, especially suitable for parenteral pH ranges. By forming API:cyclodextrin inclusion complexes, it does not only strongly increase solubility, but it can also be applied to protect from chemical degradation, reduce undesired API characteristics such as unpleasant taste and odor, and reduce aggregation in case of biologic APIs.

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

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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