Hydroxypropyl Betadex Oral Grade

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Hydroxypropyl Betadex Oral Grade

DMF No. 030168, Cas No.128446-35-5, oral grade, Hydroxypropyl betadex can be used for oral medication, injection, mucosal delivery systems (including the nasal mucosa, rectum, cornea, etc.), dermal drug delivery systems, lipophilic drugs targeting delivery, and also used as protective agent and stabilizer of protein.

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Product Description

Product Description

Hydroxypropyl Betadex Oral Grade

  • It has been approved record in U.S. FDA, DMF No. : 030168

  • Standard : USP/EP

  • Bacterial endotoxins (EU/g) : ≤20EU/g

  • Betadex : ≤1.5%

  • It is suitable for insoluble drugs to increase solubility.

Primary Competitive Advantages:

  • Possess of excellent quality guarantee system,adopt advanced testing equipment and quality manage method.

  • Hydroxypropyl Betadex is the most widely used modified cyclodextrin.

  • Hydroxypropyl Betadex has shown to change the physicochemical properties of lipophilic compounds when co-administered. Hydroxypropyl Betadex functions by forming an inclusion complex with Hydroxypropyl Betadex being administered for easier diffusion across biological membranes. The popularity of Hydroxypropyl Betadex can be attributed to its large 7 glucose unit cavity size.

 

Application:

In pharmaceuticals industry, Hydroxypropyl Betadex  can increase solubility and bioavailability of insoluble drugs, so that the efficacy of drugs can last longer with less ingestion of drugs. It can adjust and control drugs release ratio, decrease side effects of drugs, and enhance stability of drugs. Hydroxypropyl Betadex can be used for oral medication, injection, mucosal delivery systems (including the nasal mucosa, rectum, cornea, etc.), dermal drug delivery systems, lipophilic drugs targeting delivery, and also used as protective agent and stabilizer of protein.

 

Details:

 

Test Standard

USP-NF2021

 

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

 

The total aerobic microbial count

≤1000cfu/g

 

The total combined moulds and yeasts count

≤100cfu/g

 

Packaging and storage

Preserve in well-closed containers. Store at room temperature.

 

 

 

Packaging & Delivery:

Packaging Details: 10kg/drum, 20kg/drum, packed in clean workshop

 

 

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