Medicinals Cyclodextrin suppliers

fishi2fi

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Jun 21, 2019
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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 StandardUSP40-NF35
ITEMSSPECIFICATION
Molar Substitution0.40-1.50
Clarity of solution50%(w/v) water solution is clear
Identification(IR)same absorption bands as USP Hydroxypropyl Betadex RS
Loss on Drying≤10.0%
Conductivity10%(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 StandardEP9.0 Standard
ITEMSSPECIFICATION
AppearanceWhite or almost white ,amorphous or crystalline powder
SolubilityFreely soluble in water and in propylene glycol
Molar Substitution0.40-1.50
Clarity of solution50%(w/v) water solution is clear
Identification(IR)same absorption bands as Hydroxypropyl Betadex CRS
Loss on Drying≤10.0%
Conductivity10%(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 StandardUSP39-NF34
ITEMSSPECIFICATION
Molar Substitution0.40-1.50
Clarity of solution50%(w/v) water solution is clear
Identification(IR)same absorption bands as USP Hydroxypropyl Betadex RS
Loss on Drying≤10.0%
Conductivity10%(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
1Process Flow Chart
2Product Specification
3Method of Analysis
4TSE-BSE Certificate
5Residual Solvent Declaration
6No Pesticides Use Declaration
7Stability Summary Sheet(3 Batches Accelerated & Long term)
8Material Safety Data Sheet
9Packaging Material Details (Material of Construction)
10QC Instrument List
11Production Equipment List
12ISO 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.Medicinals Cyclodextrin suppliers
website:http://www.zhiyuan-cydextrin.com/medicinals-cyclodextrin/