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Product advantages:
CDE registration number:F20180001469
Injection grade hydroxypropyl beta-cyclodextrin has been registered with the US FDA, DMF registration number 030168
Qualitystandard:in line with USP- NF2021
Main use:suitable for solubilization and solubilization of injection drugs.
Bacterialendotoxin:≤10EU/g
Basic information:
Product name :Injection grade hydroxypropyl fold Cyclodextrin
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Quality :USP-NF2021
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Appearance shape :white powder
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CAS NO. :128446-35-5
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Molecular formula:C42H70-nO35(C3H7O)n
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Molecular weight :1134.98+58n
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Main Competitive Advantages:
· Quality Standard: Injection Grade
· Quality Guaranteed: Manage production in strict accordance with GMP standards.
· Obtain DMF record number: 030168
·Delivery time: cash on delivery, in stock.Zhiyuan Bio has a strong supply capacity.The annual output is 1000 tons.
· Documents: Professional domestic and foreign trade personnel, familiar with the operation process, and provide the required documents in a timely manner.
· Professional logistics and express delivery with long-term cooperation to ensure safe transportation and timely delivery.
· Pre-sale and after-sale service: Answer customer's questions in a timely manner before sale, and provide technical support after sale.
Test Standard:
CAS No.: 128446-35-5 | ||
Inspection standards | Declaration standard | |
Test items | Index | |
Traits | This product is white or off-white amorphous or crystalline powder; odorless, slightly sweet taste; easily soluble in water, soluble in methanol or ethanol, and almost insoluble in acetone or chloroform. | |
Identification | A purple ring should appear at the interface between the two liquids. | |
PH | PH5.0-7.5 | |
Solution clarity and color | 10% (W/V) aqueous solution is clear and colorless | |
Moisture | ≤6.0% | |
Chloride | ≤0.05% | |
Betacyclodextrin | ≤0.5% | |
1.2-Propanediol | ≤0.5% | |
Residue on ignition | ≤0.2% | |
Heavy metal | No more than ten millionths | |
Hydroxypropyloxy content | 16.2%-45.1% | |
Total aerobic bacteria (cfu/g) | ≤100cfu/g | |
Total mold and yeast count (cfu/g) | ≤50 cfu/g | |
Escherichia coli | Not checked out | |
Bacterial endotoxin (EU/g) | ≤20EU/g | |
Packaging and Storage
Packaging :Comply with the drug packaging
specifications:1kg/bag, 2kg/bag, 10kg/bag/drum, 20kg/bag/drum
Storage: shading, airtight save
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