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Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd
Add:Boxing Economic Development Zone, Binzhou, Shandong, China
Tel:+86-543-2616568
Fax:+86-543-2605568
E-mail: market@cydextrin.com


Oral Grade Hydroxypropyl Betadex

Hydroxypropyl Betadex Oral pharma grade USP EP CP JP BP Standard Product name: Hydroxypropyl Betadex Item No.: BZZY-002 CAS No.:128446-35-5 DMF No.:030168 Standard :CP / USP / EP/ JP/BP Grade: Oral grade / Pharma grade Basic information of the oral grade Hydroxypropyl Betadex Product Name :...

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Product Details

Hydroxypropyl Betadex Oral pharma grade USP EP CP JP BP Standard

Product name: Hydroxypropyl Betadex

Item No.: BZZY-002

CAS No.:128446-35-5

DMF No.:030168

Standard :CP / USP / EP/ JP/BP

Grade: Oral grade / Pharma grade


Basic information of the oral grade Hydroxypropyl Betadex

Product Name        : Hydroxypropyl Betadex


Synonyms            : Hydroxypropyl-β-Cyclodextrin; Hydroxypropyl beta Cyclodextrin


Molecular Formula   : C42H70-nO35(C3H8O2)n


Molecular Weight    : 1134.98+58n



Molecular structure:

1.Hydroxypropyl-Beta-Cyclodextrin Injection grade USP Standard507.png

Product Specification of Hydroxypropyl Betadex USP Standard

Test Standard

USP40-NF35

ITEMS

SPECIFICATION

Molar Substitution

0.40-1.50

Clarity of solution

50%(w/v) water solution is clear

Identification(IR)

same absorption bands as USP Hydroxypropyl Betadex RS

Loss on Drying

≤10.0%

Conductivity

10%(w/v) water solution  ≤200µS/cm

Propylene oxide

≤1ppm

Propylene glycol 

≤2.5%

Sum of Other Impurities

≤1%

Betadex

≤1.5%

Any other single impurity

≤0.25%

Heavy Metal

≤20μg/g

TAMC(cfu/g)

≤1000cfu/g

TYMC(cfu/g)

≤100cfu/g

Bacterial endotoxins (EU/g)

---


Product Specification of Hydroxypropyl Betadex EP Standard

Test Standard

EP9.0 Standard

ITEMS

SPECIFICATION

Appearance

White or almost white ,amorphous or crystalline powder

Solubility

Freely soluble in water and in propylene glycol

Molar Substitution

0.40-1.50

Clarity of solution

50%(w/v) water solution is clear

Identification(IR)

same absorption bands as Hydroxypropyl Betadex CRS

Loss on Drying

≤10.0%

Conductivity

10%(w/v) water solution  ≤200µS/cm

Related substances

Propylene glycol 

≤2.5%

Sum of Other Impurities

≤1.0%

Betadex

≤1.5%

Heavy Metal

≤20ppm

Microbial contamination

TAMC(cfu/g)

≤1000 cfu/g

TYMC(cfu/g)

≤100 cfu/g

Salmonella/E. Coli (cfu/g)

Absent

Bacterial endotoxins(IU/g)

≤10IU/g


Product Specification of Hydroxypropyl Betadex with betadex very lowest

Test Standard

USP39-NF34

ITEMS

SPECIFICATION

Molar Substitution

0.40-1.50

Clarity of solution

50%(w/v) water solution is clear

Identification(IR)

same absorption bands as USP Hydroxypropyl Betadex RS

Loss on Drying

≤10.0%

Conductivity

10%(w/v) water solution  ≤200µS/cm

Propylene oxide

≤1ppm

Propylene glycol 

≤2.5%

Sum of Other Impurities

≤1%

Betadex

≤1.5%

Any other single impurity

≤0.25%

Heavy Metal

≤20μg/g

TAMC(cfu/g)

≤1000cfu/g

TYMC(cfu/g)

≤100cfu/g

Bacterial endotoxins

(EU/g)

≤20EU/g

Main usage of Hydroxypropyl Betadex Oral pharma grade as below:

◆ To increase the solubility of medicine and biological availability

◆ To improve the bioavailability of drugs.

◆ To adjust or control the releasing of drugs.

◆ To decrease the toxicities of drugs.

◆ To improve the stabilities of drugs.


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We can supply below documents:

Documents of injection grade Hydroxypropyl-Beta-Cyclodextrin

1

Process Flow Chart

2

Product Specification

3

Method of Analysis

4

TSE-BSE Certificate

5

Residual Solvent Declaration

6

No Pesticides Use Declaration

7

Stability Summary Sheet(3 Batches Accelerated & Long term)

8

Material Safety Data Sheet

9

Packaging Material Details (Material of Construction)

10

QC Instrument List

11

Production Equipment List

12

ISO 9001 Certificate

Packing & Shipping

Packing Detail       : 500g/bag, 1kg/bag, 2kg/bag, 10kg/drum, 20kg/drum or packed according to customer’s request

Delivery

◆ Many transportation can be used,such as: DHL, UPS, TNT, EMS,by air,by sea or by train.

◆ Transport schedule ,documents and package pictures will send you check within 24 hours, tracking No will be provided within 72 Hours.

◆ Expected time left China airport and Expected time arrived in customer’s airport,Passed Customs , Out For Delivery will be sent to you timely for tracking.

1515995702(1).jpg


Payment:
We accept payments through Telex transfer, Letter of Credit or arrange payment to our Paypal account:zhiyuansw@163.com

After-sales service:

◆ Any question, welcome to consult us.

◆ we offer 7*24h good services and Tech-support.


FAQ

Does your company is a factory or trade company ?

● We are Manufacturer, we have production experience of over 8 years with a high reputation and cognition degree in the cyclodextrin field.


What's the main advantages about your Oral pharma gradeHydroxypropyl-Beta

-Cyclodextrin?

● Factory direct sale,we can provide you high quality product and competitive price.


What’s the quality assurance you provided?

● Established a procedure to check products at all stages of the manufacturing process-raw materials, process materials, validated or tested materials finished goods etc.. Besides, we have also developed a procedure which identifies the inspection and test status of all stages of the manufacturing process.

How do you control quality?

● 100% inspection in assembly lines. All controls, inspection, equipment, fixtures, total production resources and skills are inspected to ensure they consistently achieve the required quality levels. our product is under the supervision of QA and QC,firmly conforms to GMP standard.


Can purchaser come to audit?

● We warmly welcome customers' audit,it's an effective way to build a better business relationship.

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