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Product name:Oral pharmaceutical-grade hydroxypropyl beta-cyclodextrin
CAS No.:128446-35-5
DMF No.:030168
Quality standard:CP/USP/EP
Product advantages:
· CDE registration number: F20209990366
· Hydroxypropyl beta-cyclodextrin obtained the approval for the production of pharmaceutical excipients, approval number: Luyao Zhunzi F2015001
· Can provide a full set of information documents required by pharmaceutical manufacturers
· Hydroxypropyl Beta-cyclodextrin has been registered with the US FDA, DMF registration number 030168
· Quality assurance: production is managed in strict accordance with GMP standards.
· Zhiyuan Bio has a strong supply capacity, with an annual output of 3,000 tons of hydroxypropyl beta-cyclodextrin
Basic information:
Product name:Oral pharmaceutical grade hydroxypropyl beta cyclodextrin
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Molecular formula:C42H70-nO35(C3H7O)n
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Molecular weight:1134.98+58n
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Quality standard:
Inspection standards | CP2020 | USP-NF2021 |
Test items | Index | Index |
Traits | This product is white or off-white amorphous or crystalline powder.This product is very soluble in water or propylene glycol, easily soluble in methanol or ethanol, and almost insoluble in acetone or chloroform. | This product is white or off-white amorphous or crystalline powder; easily soluble in water and propylene glycol. |
Molar substitution | N/A | 0.4-1.5 |
Solution clarity and color | Should be clear and colorless | 1.0g/2ml aqueous solution is clear and transparent |
Identify | A purple ring should appear at the interface between the two liquids | The infrared spectrum shows the same absorption band (infrared) as the standard sample |
PH | PH5.0-7.5 | N/A |
Moisture | No more than 6.0% | ≤10.0% |
Conductivity | Must not exceed 200μS/cm | ≤200μS/cm |
Propylene oxide | Must not exceed 0.0001% | ≤1ppm |
1.2-Propanediol | No more than 0.5% | ≤2.5% |
Other individual impurities | No more than 0.1% | ≤0.25% |
Other total impurities (except beta cyclodextrin and 1,2-propanediol) | No more than 1.0% | ≤1.0% |
Betacyclodextrin | No more than 0.5% | ≤1.5% |
Residue on ignition | No more than 0.2% | N/A |
Heavy metal | No more than ten millionths | N/A |
Chloride | No more than 0.05% | N/A |
Hydroxypropoxy content | 19.6%～26.3% | N/A |
Total aerobic bacteria (cfu/g) | Must not exceed 100cfu/g | ≤1000cfu/g |
Total mold and yeast (cfu/g) | Must not exceed 100cfu/g | ≤100cfu/g |
Total number of pathogenic bacteria (cfu/g) | Not checked out | Not checked out |
Bacterial endotoxin | N/A | According to formulation needs |
Product performance:
The introduction of hydroxypropyl breaks the intramolecular cyclic hydrogen bond of beta cyclodextrin, and overcomes beta cyclodextrin while maintaining the cyclodextrin cavity The main disadvantage of the poor water solubility of cyclodextrins.Pharmaceutical grade hydroxypropyl beta-cyclodextrin is an ideal injection solubilizer and pharmaceutical excipient. Its main functions in the field of medicine are as follows:
1. Solubilization and solubilization, solubilization of poorly soluble drugs, and improvement of the active ingredients of oily drugs Solubility, targeted drug delivery and protection of drug ingredient effectiveness.
2. Improve the bioavailability of the drug, so that the curative effect of the drug is increased or the dosage is decreased.
3. Adjust or control the release rate of the drug and reduce the toxic and side effects of the drug.
4. Cover up bad smell.
Scope of application:Pharmaceutical grade hydroxypropyl beta cyclodextrin can be used for oral drugs, injections, mucosal drug delivery systems (including nasal mucosa, rectum, cornea, etc.), It is a transdermal drug delivery system, a carrier for lipophilic targeted drugs, and can also be used as a protein protector and stabilizer.
Packaging andstorage:
Packaging: Inline with pharmaceutical packaging
Specifications:0.1kg/bag, 1kg/bag, 2kg/bag, 10kg/bag/drum, 20kg/ Bag/drum
Storage: shading, airtight storage
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