1.42020

Cyclodextrin HPB

EMPROVE^® EXPERT, Ph. Eur., NF

• Synonym(s): Cyclodextrin HPB, (2-Hydroxypropyl)-β-Cyclodextrin, HP-B-CD, Hydroxypropyl Betadex
• Linear Formula: C₄₂H_70-nO₃₅ · (C₃H₇O)_n
• CAS Number: 128446-35-5
• MDL number: MFCD00004860
• UNSPSC Code: 12352201

Properties

• 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

Description

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

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 1
• flash_point_f: 752.0 °F
• flash_point_c: > 400 °C