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Cyclodextrin HPB

EMPROVE® EXPERT, Ph. Eur., NF

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
UNSPSC Code:
12352201
MDL number:
MFCD00004860
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Quality Level

500

agency

NF, Ph. Eur.

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

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

11 - Combustible Solids

wgk

WGK 1

flash_point_f

>752.0 °F

flash_point_c

> 400 °C

Regulatory Information

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Articles

Overcoming Excipient Risks and Challenges for Parenteral Formulations

This overview describes the challenges when developing parenteral formulations and strategies to overcome them and reduce the risk of production.

Liquid Formulation Solubility Enhancement

Discover strategies to enhance solubility in injectable formulations using excipients, including cyclodextrins, meglumine, and polyethylene glycols.

Use of Stabilizers and Surfactants to Prevent Protein Aggregation

This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.

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