182410-00-0 Injection grade sulfobutyl ether beta cyclodextrin sodium SBECD
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Product Name
182410-00-0 Injection grade sulfobutyl ether beta cyclodextrin sodium SBECD
Manufacturer(s)
Specifications
- Test Items: USP Standard
- Clarity of solution: A 30%w/v solution in water is clear
- Identification (IR): Same absorption bands as USP betadex sulfobutyl ether sodium RS
- Average Degree of Substitution: 6.2-6.9
- Water solution pH: pH of 30%w/v solution in water is 4.0-6.8
- Water content: ≤10.0%
- Sodium Chloride: ≤0.2%
- 1,4-Butane Sultone: ≤0.5ppm
- 4-Hydroxybutane-1-sulfonic Acid: ≤0.09%
- Assay: 95.0%-105.0%
- Bacterial endotoxins: ≤20EU/g
- Escherichia coli: Absence
Documents
ISO9001
ISO14001
ISO45001
FDA filing and registration
CEP certificates
GMP standard workshop
GMP clean workshop
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