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Sulfobutylated beta-cyclodextrin sodium salt CAS NO.182410-00-0
- Min.Order: 1 Kilogram
- Payment Terms:
- Product Details
Keywords
- Captisol
- Dexolve
- SBECD
Quick Details
- ProName: Sulfobutylated beta-cyclodextrin sodiu...
- CasNo: 182410-00-0
- Molecular Formula: C42H70-nO35 · (C4H8O3SNa)n
- Appearance: white powder
- Application: parenterals, oral formulations, solubi...
- ProductionCapacity: Metric Ton/Day
- Purity: >95%, USP NF grade
- Storage: RT
- LimitNum: 1 Kilogram
Superiority
Appearance
| Visual | white or off-white powder | |
| Identification A | IR (USP <197>, EP 2.2.24) | complies with SBECD reference |
| Identification B | HPLC (USP <621>, EP 2.2.29) | tR of major peak complies with SBECD reference |
| Identification C | CE (USP <1053>, EP 2.2.47) | Average Degree of Substitution: 6.2 - 6.9 |
| Identification D | Sodium ID (USP <191>, EP 2.3.1) | positive test |
| Identification E | NMR (USP <761> EP 2.2.33) | Average Degree of Substitution: 5.9 - 6.6 |
| Assay | HPLC (USP <621>, EP 2.2.29) | 95.0 - 105.0% on the anhydrous basis |
| Heavy metals | EP 2.4.8 B | NMT 5 ppm |
|
Limit of related substances beta-cyclodextrin (Betadex) total other impurities |
HPLC (USP <621>, EP 2.2.29) |
NMT 0.1% NMT 1.0% |
| Limit of 1,4-Butane Sultone | GC (USP <621>, EP 2.2.28) | NMT 0.5 ppm |
| Limit of Sodium Chloride | Limit test (USP <221>) | NMT 0.2% |
| Limit of 4-Hydroxybutane-1-sulfonic Acid | CE (USP <1053>, EP 2.2.47) | NMT 0.09% |
| Limit of Bis(4-sulfobutyl) Ether Disodium | CE (USP <1053>, EP 2.2.47) | NMT 0.05% |
| Bacterial Endotoxin Test | EP-USP harmonized method | ≤ 24 IU/g |
| Microbial Enumeration Tests | EP-USP harmonized method |
TAMC ≤ 100 cfu/g TYMC ≤ 50 cfu/g |
| Test for Specified Microorganism | EP-USP harmonized method | absence of Escherichia Coli /1 g |
| Phosphate content | UV-Vis Spectroscopy (USP <851>, EP 2.2.25) | 125 - 300 μg/gd |
| Clarity of solution (30%, w/v) | Visual, see details in the USP Monograph, EP 2.2.1 | the solution is clear, and essentially free from particles of foreign matter |
| Average Degree of Substitution (n) | NMR (USP <761> EP 2.2.33) | 5.9 - 6.6 |
| Average Degree of Substitution (n) | CE (USP <1053>, EP 2.2.47) | 6.2 - 6.9 |
| Peak distribution | CE (USP <1053>, EP 2.2.47) |
each SBECD peak (I-X) meets the limit range (peak area %) of the Monograph SBECD sodium Limit range peaks (% peak area) I (DS-1) 0 - 0.3 II (DS-2) 0 - 0.9 III (DS-3) 0.5 - 5.0 IV (DS-4) 2.0 - 10.0 V (DS-5) 10.0 - 20.0 VI (DS-6) 15.0 - 25.0 VII (DS-7) 20.0 - 30.0 VII (DS-8) 10.0 - 25.0 IX (DS-9) 2.0 - 12.0 X (DS-10) 0 - 4.0 |