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Key Documents

1.42020

SAFC

Cyclodextrin HPB

EMPROVE® EXPERT, Ph. Eur., NF

Fabrication pharma

Synonyme(s) :

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

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About This Item

Formule linéaire :
C42H70-nO35 · (C3H7O)n
Numéro CAS:
Code UNSPSC :
12352201

Agence

NF
Ph. Eur.

Niveau de qualité

Gamme de produits

EMPROVE® EXPERT

Forme

solid

Poids mol.

avg mol wt 1387.2 g/mol

pH

5.0-7.0 (20 g/L in H2O)

Solubilité

450 g/L

Application(s)

liquid formulation
ophthalmics
pharmaceutical
solid formulation
solubility enhancement

Température de stockage

15-25°C

Description générale

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.

Informations légales

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

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 1

Point d'éclair (°F)

752.0 °F

Point d'éclair (°C)

> 400 °C


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Articles

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

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

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

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

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