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Hydroxypropyl Betadex 128446-35-5 Injection Grade
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Hydroxypropyl Betadex 128446-35-5 Injection Grade

Hydroxypropyl betadex is an ideal injection solubilizer and drug excipients because of lower surface activity and hemolytic activity, no muscle irritation.
  • HPBCD
  • 128446-35-5

Hydroxypropyl Betadex

CAS No.: 128446-35-5

 

Quick Details

Product Name

Hydroxypropyl Betadex

CAS No.

128446-35-5

Other Names

hpbcd,HPBCD

Appearance

White powder,sweet,insipid innocent

Molecular Formula 

C42H70-nO35(C3H8O2)n

Molecular Weight 

1134.98+58n

Standard

CP, USP, EP, In-house Standard

Solubility

≥100(25℃,g/100ml)

 

Product Specification

Test Standard

USP43-NF38

ITEMS

criteria

Appearance

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

Identification

IR

Same absorption bands as USP Hydroxypropyl Betadex RS

Clarity of Solution

Positive

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

≤1ppm

Loss on Drying

≤10.0%

Clarity of Solution

1.0g/2ml water solution is clear and transparent

Conductivity

≤200µS/cm

Bacterial Endotoxins Test

According to preparation needs

The total aerobic microbial count

≤1000cfu/g

The total combined moulds and yeasts count

≤100cfu/g


Product features 

Hydroxypropyl betadex is a hydroxyalkyl derivative of beta cyclodextrin. It is non-toxic and has no side effects. 

Due to its special structure, it can greatly improve the solubility of insoluble drugs and make the insoluble or insoluble drugs dissolve in water. 

Therefore, it can effectively improve the bioavailability of drugs, greatly improve the drug quality and dosage forms, and is widely used in the development and production of new drugs.  


Application

1. Hydroxypropyl betadex is an ideal injection solubilizer and drug excipients because of lower surface activity and hemolytic activity, no muscle irritation.

2.It can increase the solubility of the medicine and biological availability, also increase durg's curative effect thus decrease the dose.

3. Meanwhile,it can control drug release rate, lower drug toxicity and enhance stability.

4. It is not only be used in oral drugs, injection, mucosal drug delivery system, transdermal drug delivery system, lipotropy targeting drug carrier, but also can be used as protein protective agent and stabilizer.


Bacterial endotoxin control

In the production process of Hydroxypropyl betadex,the cleaning of nanofiltration machine, cationic resin, filter element and storage of materials in semi-hermetic state are the main factors affecting the bacterial endotoxin. 

In order to ensure that the products of bacterial endotoxin qualified, we strictly control each of the key influencing factors, to prevent the traditional sense of the impurities in the resin and filter products to bacterial endotoxin source of pollution, in accordance with drug production management requirements, to minimize the production process in the pollution, the risk of cross-contamination, to ensure sustained and stable production to meet user quality standards of products.


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