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2-Hydroxypropyl-β-Cyclodextrin
CAS NO.: 128446-35-5
FOB Price: NEGOTIABLE Get Latest Price
Specification: CP/USP/EP
Documentation:
Lead Time: 14-30 days
Max Capacity: 1000MT/Year
Packing: 1KG/Paper Bag; 20KG/Paper Bag; Customed Package
Product Detail
Properties

Oral Pharmaceutical Grade hydroxypropyl beta cyclodextrin

Product name:Oral pharmaceutical-grade hydroxypropyl beta-cyclodextrin

CAS No.:128446-35-5

DMF No.:030168

Quality standard:CP/USP/EP

Product advantages:

· CDE registration number: F20209990366

· Hydroxypropyl beta-cyclodextrin obtained the approval for the production of pharmaceutical excipients, approval number: Luyao Zhunzi F2015001

· Can provide a full set of information documents required by pharmaceutical manufacturers

· Hydroxypropyl Beta-cyclodextrin has been registered with the US FDA, DMF registration number 030168 

· Quality assurance: production is managed in strict accordance with GMP standards.

· Zhiyuan Bio has a strong supply capacity, with an annual output of 3,000 tons of hydroxypropyl beta-cyclodextrin


Basic information:

Product name:Oral pharmaceutical grade hydroxypropyl beta cyclodextrin

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Molecular formula:C42H70-nO35(C3H7O)n

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Molecular weight:1134.98+58n

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Quality standard:


 Inspection standards

 CP2020

 USP-NF2021

 Test items

 Index

 Index

 Traits

 This product is white or off-white amorphous or crystalline powder.This product is very soluble in water or propylene glycol, easily soluble in methanol or ethanol, and almost insoluble in acetone or chloroform.

   This product is white or off-white amorphous or crystalline powder; easily soluble in water and propylene glycol.

 Molar substitution

 N/A

 0.4-1.5

 Solution clarity and color

 Should be clear and colorless

 1.0g/2ml aqueous solution is clear and transparent

 Identify

 A purple ring should appear at the interface between the two liquids

 The infrared spectrum shows the same absorption band (infrared) as the standard sample

 PH

 PH5.0-7.5

 N/A

 Moisture

 No more than 6.0%

 ≤10.0%

 Conductivity

 Must not exceed 200μS/cm

 ≤200μS/cm

 Propylene oxide

 Must not exceed 0.0001%

 ≤1ppm

 1.2-Propanediol 

 No more than 0.5%

 ≤2.5%

 Other individual impurities

 No more than 0.1%

 ≤0.25%

 Other total impurities (except beta cyclodextrin and 1,2-propanediol)

 No more than 1.0%

  ≤1.0%

 Betacyclodextrin

 No more than 0.5%

 ≤1.5%

 Residue on ignition

 No more than 0.2%

 N/A

 Heavy metal

 No more than ten millionths

 N/A

 Chloride

 No more than 0.05%

 N/A

 Hydroxypropoxy content

 19.6%~26.3%

 N/A

 Total aerobic bacteria (cfu/g)

 Must not exceed 100cfu/g

 ≤1000cfu/g

 Total mold and yeast (cfu/g)

 Must not exceed 100cfu/g

 ≤100cfu/g

 Total number of pathogenic bacteria (cfu/g)

 Not checked out

 Not checked out

 Bacterial endotoxin

 N/A

 According to formulation needs


Product performance:

The introduction of hydroxypropyl breaks the intramolecular cyclic hydrogen bond of beta cyclodextrin, and overcomes beta cyclodextrin while maintaining the cyclodextrin cavity The main disadvantage of the poor water solubility of cyclodextrins.Pharmaceutical grade hydroxypropyl beta-cyclodextrin is an ideal injection solubilizer and pharmaceutical excipient. Its main functions in the field of medicine are as follows:

1. Solubilization and solubilization, solubilization of poorly soluble drugs, and improvement of the active ingredients of oily drugs Solubility, targeted drug delivery and protection of drug ingredient effectiveness.

2. Improve the bioavailability of the drug, so that the curative effect of the drug is increased or the dosage is decreased.

3. Adjust or control the release rate of the drug and reduce the toxic and side effects of the drug.

4. Cover up bad smell.

Scope of application:Pharmaceutical grade hydroxypropyl beta cyclodextrin can be used for oral drugs, injections, mucosal drug delivery systems (including nasal mucosa, rectum, cornea, etc.), It is a transdermal drug delivery system, a carrier for lipophilic targeted drugs, and can also be used as a protein protector and stabilizer.


Packaging andstorage:

Packaging: Inline with pharmaceutical packaging

Specifications:0.1kg/bag, 1kg/bag, 2kg/bag, 10kg/bag/drum, 20kg/ Bag/drum

Storage: shading, airtight storage


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14YRS
Business Type:
CRO
Country/Region:
Shandong, China
Contacts:
Zhao Dabo
Position Title:
Manager of foreign trade department
Tel:
0086-531-88916568
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