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Documenti

1.42020

SAFC

Cyclodextrin HPB

EMPROVE® EXPERT, Ph. Eur., NF

Produzione farmaceutica

Sinonimo/i:

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

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About This Item

Formula condensata:
C42H70-nO35 · (C3H7O)n
Numero CAS:
128446-35-5
Codice UNSPSC:
12352201

agenzia

NF
Ph. Eur.

Livello qualitativo

500

Nome Commerciale

EMPROVE® EXPERT

Forma fisica

solid

PM

avg mol wt 1387.2 g/mol

pH

5.0-7.0 (20 g/L in H2O)

Solubilità

450 g/L

applicazioni

liquid formulation
ophthalmics
pharmaceutical
solid formulation
solubility enhancement

Temperatura di conservazione

15-25°C

Descrizione generale

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.

Applicazioni

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.

Note legali

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

Codice della classe di stoccaggio

11 - Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 1

Punto d’infiammabilità (°F)

752.0 °F

Punto d’infiammabilità (°C)

> 400 °C

Certificati d'analisi (COA)

Cerca il Certificati d'analisi (COA) digitando il numero di lotto/batch corrispondente. I numeri di lotto o di batch sono stampati sull'etichetta dei prodotti dopo la parola ‘Lotto’ o ‘Batch’.

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(2-Hydroxypropyl)-β-cyclodextrin solution

Sigma-Aldrich

H5784

(2-Hydroxypropyl)-β-cyclodextrin solution

β-ciclodestrina European Pharmacopoeia (EP) Reference Standard

B0950000

β-ciclodestrina

(2-Hydroxypropyl)-γ-cyclodextrin Produced by Wacker Chemie AG, Burghausen, Germany, Life Science

Sigma-Aldrich

779229

(2-Hydroxypropyl)-γ-cyclodextrin

USP

USP

1065550

Betadex sulfobutyl ether sodium

(2-Hydroxypropyl)-γ-cyclodextrin solid

Sigma-Aldrich

H125

(2-Hydroxypropyl)-γ-cyclodextrin

α-Cyclodextrin ≥98%

Sigma-Aldrich

C4642

α-Cyclodextrin

γ-Cyclodextrin ≥98%

Sigma-Aldrich

C4892

γ-Cyclodextrin

β-ciclodestrina ≥97%

Sigma-Aldrich

C4767

β-ciclodestrina

Articoli

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.

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.

Il team dei nostri ricercatori vanta grande esperienza in tutte le aree della ricerca quali Life Science, scienza dei materiali, sintesi chimica, cromatografia, discipline analitiche, ecc..

Contatta l'Assistenza Tecnica.