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:
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/