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        : Hydroxypropyl Betadex

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Synonyms            : Hydroxypropyl-β-Cyclodextrin; Hydroxypropyl beta Cyclodextrin

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Molecular Formula   : C₄₂H_70-nO₃₅(C₃H₈O₂)n

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Molecular Weight    : 1134.98+58n

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Molecular structure:

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	≤20
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.

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.

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.

http://www.zhiyuan-cydextrin.com/