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1.42020

SAFC

Cyclodextrin HPB

EMPROVE® EXPERT, Ph. Eur., NF

Pharma Manufacturing

Synonym(s):

Cyclodextrin HPB, (2-Hydroxypropyl)-β-Cyclodextrin, HP-B-CD, Hydroxypropyl Betadex

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About This Item

Linear Formula:
C42H70-nO35 · (C3H7O)n
CAS Number:
128446-35-5
MDL number:
MFCD00004860
UNSPSC Code:
12352201
Pricing and availability is not currently available.

Agency

NF
Ph. Eur.

Quality Level

500

product line

EMPROVE® EXPERT

form

solid

mol wt

avg mol wt 1387.2 g/mol

pH

5.0-7.0 (20 g/L in H2O)

solubility

450 g/L

application(s)

liquid formulation
ophthalmics
pharmaceutical
solid formulation
solubility enhancement

storage temp.

15-25°C

Related Categories

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

Cyclodextrin HPB (hydroxypylated β-cyclodextrin) can be used to strongly increase solubility of active pharmaceutical ingredients (APIs) by forming API:cyclodextrin inclusion complexes. It can also increase API stability and safety as well as mask undesired odors and tastes. The broad application range of Cyclodextrin HPB comprises liquid, semi-solid and solid formulations, as well as diverse routes of administration. Due to its low microbial and endotoxin limits, Cyclodextrin HPB Emprove® Expert is especially suitable for high-risk applications.

Legal Information

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

752.0 °F

Flash Point(C)

> 400 °C

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

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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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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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