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Hydroxypropyl Betadex Pharmaceutical excipient Injection grade USP Standard
Time：2022/06/18

Hydroxypropyl Betadex Pharmaceutical excipient  Injection grade USP Standard 

Quick Details

Product NameHydroxypropyl Betadex injection grade
CAS No.128446-35-5
Other Nameshpbcd,HPBCD
AppearanceWhite powder,sweet,insipid innocent
MOQ1kg
SampleFree of Charge
Molecular Formula C42H70-nO35(C3H8O2)n
Molecular Weight 1134.98+58n
TypeAuxiliaries and Other Medicinal Chemicals
Grade StandardMedicine Grade
PackageDrum or carton
Brand NameBinzhou
Purity99%min
Shelf life36 months
GradeInjection
StandardUSP, EP, In-house Standard
ApplicationPharmaceuticals
Solubility≥100(25℃,g/100ml)
Factory or Trade companyDirect Factory
Place of OriginShandong, China (Mainland)

Molecular structure:







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About Zhiyuan Injection grade Hydroxypropyl-Beta-Cyclodextrin 

  • It has been approved record in U.S. FDA, DMF NO. : 030168

  • Standard : USP

  • Bacterial endotoxins (EU/g) : ≤20EU/g

  • Betadex : ≤0.1%

  • It is suitable for injection drugs.The main function is to increase solubility.


Primary Competitive Advantages:

  • Possess of excellent quality guarantee system,adopt advanced testing equipment and Quality manage method.

  • Experienced Staff & Advanced production technology & Stable quality

  • Factory Price

  • Prompt Delivery

  • Quality Approvals

  • Small Orders Accepted

  • Delivery immediately


Product Specification


 Hydroxypropyl Betadex injection grade
Test StandardUSP
ITEMSSPECIFICATION
Appearance

White or almost white, amorphous or

 crystalline powder. Freely soluble in water and in propylene glycol.

IdentificationIR

same absorption bands as USP Hydroxypropy

l Betadex RS

Clarity of SolutionPositive
Molar Substitution0.40-1.50
Betadex≤1.5%
Propylene Glycol≤2.5%
Any Other Single Impurity≤0.25％

Total Impurities Excluding Betadex 

and Propylene Glycol

≤1.0％
Propylene Oxide≤1ppm
Loss on Drying≤10.0％
Clarity of Solution50%(w/v) water solution is clear
Conductivity≤200µS/cm
Bacterial Endotoxins≤20EU/g
The total aerobic microbial count≤1000cfu/g
The total combined moulds and yeasts count≤100cfu/g
Packaging and storage

Preserve in well-closed containers. Store at

 room temperature.

 Packaging & Delivery

Packaging Details: 10kg/drum,packed in clean workshop

Port: Qingdao,Beijing,Shanghai,Tianjin

Lead Time :

Quantity(Kilograms)1-1000(kg)>1000(kg)
 Est. Time(day)5To be negotiated

 

Q:What is the difference between the indicators of hydroxypropyl beta cyclodextrin injection grade and oral grade?
A:The difference between the oral grade and injection grade of hydroxypropyl beta cyclodextrin is reflected in two points:
The first is that hydroxypropyl beta cyclodextrin injection grade increases the index control of bacterial endotoxin, requiring bacterial endotoxin to be less than 0.01EU/mg.
The second is that the  hydroxypropyl beta cyclodextrin injection grade has higher requirements for the residual index of beta-cyclodextrin: <0.1%.
Q:What are the preparations of hydroxypropyl betacyclodextrin currently being developed or marketed?
A:Preparations include Butylphthalide injection, Itraconazole injection, Letermovir injection, Telavancin injection, etc.
Q:What are the differences between hydroxypropyl beta cyclodextrin, 2-hydroxypropyl beta cyclodextrin and (2-hydroxypropyl) beta cyclodextrin?
A:1. The Arabic numerals in the name of hydroxypropyl beta cyclodextrin usually indicate the modification position.
2. Cyclodextrins can be substituted at positions 2, 3 and 6 in the sugar unit. The 2-position substitution of commercially available hydroxypropyl beta cyclodextrin accounts for about 50-60%. 2-Hydroxypropyl beta cyclodextrin refers to hydroxypropyl beta cyclodextrin substituted by 2-position cyclodextrin, which is difficult to produce and generally only used for scientific research.
3. Another hydroxypropyl group has two isomers (2-hydroxypropyl) and (3-hydroxypropyl). The commercially available hydroxypropyl beta cyclodextrin is (2-hydroxypropyl) beta-cyclodextrin, where 2 represents the 2-position of the propyl group instead of the 2-position of the cyclodextrin.
Q:Why does hydroxypropyl beta cyclodextrin have two CAS numbers, 128446-35-5 and 94035-02-6?
A:Cas numbers such as ID numbers are unique. However, hydroxypropyl beta cyclodextrin itself is a mixture, and there are many isomers. The official Cas organization Scifinder gave hydroxypropyl beta cyclodextrin two CAS numbers in the early days. At present, the two numbers have been merged and it is recommended to delete 94035 -02-6. 128446-35-5 is used in the Chinese Pharmacopoeia, and 128446-35-5 is also used in the US Pharmacopoeia.
Q:What is the advantage of shydroxypropyl beta cyclodextrin of Zhiyuan Biotechnology compared with other counterparts?
A:First, through the comparative test of UV absorbance, the impurity content of Zhiyuan Biotechnology products is the least, which is obviously due to the level of the same industry at home and abroad.
Second, through the comparative detection of the inclusion efficiency of 6-methylcoumarin, the products of the Chinese Pharmacopoeia standard of Zhiyuan Biotechnology and the European Pharmacopoeia and American Pharmacopoeia have stronger packaging capacity and higher packaging efficiency than similar products. 
Q:What is the formula of the corresponding relationship between the molar substitution degree and the hydroxypropyloxy content in the Chinese Pharmacopoeia and the US Pharmacopoeia of hydroxypropyl beta cyclodextrin?
A:1. Because a beta cyclodextrin molecule is composed of 7 glucose unit molecules, the relationship between the average substitution degree and the molar substitution degree is 7 times: average substitution degree = molar substitution degree * 7.
2. The index indicating the degree of substitution in the Chinese Pharmacopoeia is the content of hydroxypropyloxy group, and in the European and American Pharmacopoeia is the degree of molar substitution, and the formula conversion relationship is as follows:
n=1135A/(75-58A)
n is the average degree of substitution, A is the hydroxypropoxy content
Q:What are the degrees of substitution of hydroxypropyl beta cyclodextrin?
A:Generally, there are three degrees of substitution. One is 4.5-5.0 (it can also be understood as ≤5.0, and complies with ChP, USP, EP); one is 5.0-6.0 (complies with USP); the other is customized products.
Q: Why can't hydroxypropyl beta-cyclodextrin be used in food?
Answer: 1. It has not entered the catalogue of food additives in China, and cannot be used in food according to regulations (Alpha cyclodextrin, beta cyclodextrin, and gamma cyclodextrin have entered the catalogue of food additives),
2. In foreign countries, there are only three parent cyclodextrins, alpha, beta and gamma, in the food additives given by the Food and Agriculture Organization of the United Nations.
Q:What is the solubility of hydroxypropyl beta cyclodextrin in water?
A:1. When the degree of substitution is 4.2, the solubility in water: >100g/(100g water, 20℃)
2. When the degree of substitution is 5.3, the solubility in water: >115g/(100g water, 20℃)
Q: What is the use of technical grade hydroxypropyl beta cyclodextrin?
A:1. It belongs to the enterprise standard and is mainly used in veterinary medicine, industry, daily chemical and other industries.
2. Popular science: The GMP we are talking about refers to "Good Manufacturing Practice for Drugs"; the reference for veterinary drug production is "GMP for Veterinary Drugs > "Good Manufacturing Practice for Veterinary Drugs";
For industrial use, please refer to the management system of IS09001.
Q: What is the difference between hydroxypropyl beta cyclodextrin injection grade and other grades?
A:1. There are requirements for bacterial endotoxin.
2. There are requirements for bacterial endotoxin, and the residue of beta-cyclodextrin is less than 0.1%. The conductivity is between 30-50μs/cm. 
Q:Why is sodium sulfobutyl beta cyclodextrin more expensive than hydroxypropyl beta cyclodextrin?
A:SBECD and HPBCD are different due to the production cost. For the types of inclusion drugs, HPBCD is generally positioned as a central nervous system drug; SBECD is generally an antifungal drug. For the types of inclusion drugs, please refer to the following table:
Hydroxypropyl beta cyclodextrin: as biocompatibility enhancement, complexing agent, solubilizer, osmotic agent, stabilizer, diluent for tablets or capsules, viscosity increasing agent, water reducing activity, etc., used in Injections, oral solid preparations, ophthalmic preparations, intranasal preparations, inhalation preparations and external preparations can also be used as carriers for lipophilic targeted drugs and as protein protectors and stabilizers.
Sulfobutyl beta cyclodextrin sodium: Increase drug solubility, improve bioavailability; increase drug stability; relieve and improve local irritation; adjust drug release; enhance drug absorption and utilization. It has applications in injection preparations, oral preparations, intranasal preparations and ophthalmic preparations.
Q: Is there any introduction of heavy metal elements in the production process of cyclodextrin?
A: 1. No.
2. For heavy metals in hydroxypropyl beta cyclodextrin and sulfobutyl beta cyclodextrin sodium, we have formulated an elemental analysis report with reference to the guidelines of Q3D in ICH, and the content of each heavy metal element can be effectively controlled. For specific data, please refer to the elemental analysis report.
3. For the detection of heavy metal content in other products, we refer to the “Chinese Pharmacopoeia” 2020 edition of the four general chapters 0821 for control.
Q: What guiding principles are used for elemental impurity analysis?
A: For the heavy metals in hydroxypropyl beta cyclodextrin and sulfobutyl beta cyclodextrin sodium, we have formulated an elemental analysis report with reference to the Q3D guidelines in ICH, and the content of each heavy metal element can be effectively controlled. For specific data, please refer to the elemental analysis report.
Q: How to understand the expiration date of the product?
A: 1. The validity period of cyclodextrin excipients refers to the re-inspection period, and it is not broken when it expires
2. After the API is made, the cyclodextrin has changed, and it is not possible to simply look at the cyclodextrin. At this time, it is a new substance, which is jointly processed by the cyclodextrin and the API. Its stability cannot be determined solely by the validity period of its constituents.
For example, the raw and auxiliary materials for the production of API in general factories will have a re-inspection period of about 1 year, but the validity period of the produced API is calculated from the time of production, and the validity period of the preparation should be calculated from the production of the preparation.
Q: How many years is the product validity period?
A: The shelf life of hydroxypropyl beta cyclodextrin is 2 years from the date of production and stored in accordance with the specified storage conditions. Storage past the expiration date on the label does not necessarily mean the product is no longer usable. In this case, however, for quality assurance reasons, the user must check to confirm the performance required for the intended use.
Q: 1. Why is the test report of hydroxypropyl beta-cyclodextrin not pure?
A: All pharmacopoeia, including Chinese Pharmacopoeia and US Pharmacopoeia, do not stipulate the measurement of purity. At present, there is no detection method, and there is no standard substance for liquid phase detection, so purity cannot be detected. Hydroxypropyl beta-cyclodextrin itself is a mixture, the average degree of substitution is 2.8-10.5, and the degree of substitution may be 3 or 5. We can generally calculate it based on other indicators tested?
(100-burning residue-beta content%-chloride)/(100-moisture%)

2. In the Chinese Pharmacopoeia, the content of hydroxypropoxy group (19.6%-26.3%) is measured, and the average degree of substitution (3.5-5.0) is calculated by formula.
Formula: n=1135A/(75-58A)
n is the average degree of substitution, A is the hydroxypropoxy content
The hydroxypropoxy content is the mass content of hydroxypropyl in the whole product. It can be calculated by the total substitution degree: hydroxypropoxy content=75n/(58n+1135) n is the average substitution degree

3. Foreign is the molar degree of substitution, the molar degree of substitution X7 = the average degree of substitution
Q: The difference between technical grade hydroxypropyl beta cyclodextrin and pharmaceutical grade hydroxypropyl beta cyclodextrin:
A: 1. Impurity residues are different: there are more technical grade impurities, such as sodium chloride, propylene glycol, etc.
2. The average degree of substitution is different: the degree of substitution of technical grade is 4-6, and the degree of substitution of pharmaceutical grade is 3.5-5
3. The control of indicators such as microorganisms is different: the technical level does not control microbial endotoxins, etc.
4. The effective content is different: the effective content of technical grade is more than 96% lower, and the content of oral grade is more than 98%
5.CP pharmaceutical grade has no electrical conductivity, no chloride, it is the content of hydroxypropoxy and no substitution index.
Q: Compared with peers, what are the product advantages of our company?
A: 1. The output is the largest in the same industry, at 2,000 tons per year
2. The degree of substitution is in line with the customer's use, mainly used as a dispersant
3. The best price
4. Can provide 50% aqueous solution with lower cost


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