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Hydroxypropyl Beta Cyclodextrin

Hydroxypropyl beta Cyclodextrin has the characteristics of ultra-low beta Cyclodextrin residue, which is suitable for solubilization and solubilization of injection drugs.Completed US FDA record, DMF No.: 030168, Strictly follow GMP standards for production.
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Quick Details

Name

Hydroxypropyl beta Cyclodextrin

CAS No.

128446-35-5

Molecular Formula

C42H70-nO35(C3H7O)n

Molecular Weight

1134.98+58n

Appearance

white powder, insipid, innocent

Assay

≥98%

Classification

Injection Grade


Quality standard

USP/CP/EP Standard


Product Introduction

Hydroxypropyl beta Cyclodextrin (HP-β-CD)is a hydroxyalkylated derivative of beta Cyclodextrin(β-CD). Hydroxypropyl β cyclodextrin is non-toxic and has no side effects. Due to its special structure, it can greatly improve the solubility of insoluble drugs, making insoluble or insoluble drugs soluble in water. Therefore, it can effectively improve the bio availability of drugs, greatly improve drug quality and dosage form varieties, and is widely used in the development and production of new drugs.

Hydroxypropyl beta Cyclodextrin manufacturer-Shandong Binzhou Zhiyuan Biotechnology Co., Ltd which has completed registration with FDA, and the registration information is as follows:

Company name: Shandong Binzhou Zhiyuan Biotechnology Co., Ltd

FDA ESTABLISHMENT IDENTIFIER (FEI No.):3011680310

ESTABLISHMENT ADDRESS: Boxing Economic Development Zone,, Binzhou, Shandong 256500, China (CHN)

DUNS: 548171477


Product Specification

Test Standard

USP-NF2023

ITEMS

CRITERIA

Appearance

White or almost white, amorphous or crystalline powder. Freely soluble in water and in propylene glycol.

Molar substitution

0.40~1.50

Betadex

≤1.5%

Propylene glycol

≤2.5%

Any other single impurity

≤0.25%

Total impurities excluding betadex and propylene glycol

≤1.0%

Propylene oxide

≤0.0001%

Loss on drying

≤10.0%

Clarity of solution

1.0g/2ml water solution is clear and transparent

Conductivity

≤200μS/cm

Bacterial Endotoxins Test

≤10EU/g

The total aerobic microbial count

≤1000cfu/g

The total combined molds and yeasts count

≤100 cfu/g


Features

Hydroxypropyl beta Cyclodextrin usp standard has the characteristics of ultra-low beta Cyclodextrin residue, which is suitable for solubilization and solubilization of injection drugs.


Application

Hydroxypropyl beta Cyclodextrin is an ideal solubilizer and excipient for injection.

1. Solubilization and solubilization, dissolve insoluble drugs, improve the solubility of Active ingredient of oily drugs, target drug delivery and protect the effectiveness of drug ingredients.

2. Improve the bioavailability of drugs to increase their efficacy or reduce their dosage.

3. Adjust or control the release rate of drugs to reduce drug toxicity and side effects.

4. Cover up bad odors. Hydroxypropyl beta Cyclodextrin can be used for injections, mucosal drug delivery systems (including nasal mucosa, rectum, cornea, etc.), transdermal drug delivery systems, carriers of Lipophilicity targeted drugs, as well as as protein protectors and stabilizers.


Packing & Storage

Packing Detail: 

10 kg/bag, 20 kg/bag

Internal packing: packed PE bag, then put into aluminum foil bag

Outer packing: packed in carton or drum.

Label according to customers' request.

Storage:

Hydroxypropyl beta Cyclodextrin has a shelf life of at least 36 months when stored in unbroken original packaging in dry storage areas. Storage beyond the date specified on the label does not necessarily mean that the product is no longer usable. In this case however, the properties required for the intended use must be checked for quality assurance reasons.

Storage at room temperature in sealed containers under dry conditions is recommended.


Delivery

Stock: Adequate inventory

Delivery : Delivery goods within 1-3 workdays.

Loading location: factory of Binzhou Zhiyuan(China)

We can supply DDU service,FOB, CFR, or CIF service;

For high value products, please select air shipping and express delivery for safety.


FAQ

Do you accept sample order?

We provide free samples.

How to confirm the product quality before placing orders?

It is recommended to test the quality of the samples before placing an order, as we can ensure that the quality of the order is consistent with the quality of the samples.

Do you supply product report?

Yes. We'll give you product analysis report before shipping.

Is there a discount?

Different quantity has different discount.



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