Sulfobutylated beta-cyclodextrin sodium salt (DS~6.5)

(CODE: 47)


Abbreviation: SBECD
CAS Number: 182410-00-0
Product Number: 47
Cyclodextrin type: Anionic cyclodextrins
Quality: pharma grade
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Chemical and Physical Description
Average Molecular Formula C42H70-nO35 · (C4H8O3SNa)n
Average Formula Weight 1135.0 + n·(158.2)
Possible impurities 4-Hydroxybutane-1-sulfonic acid sodium salt, bis(4-sulfobutyl) ether disodium, residual beta-cyclodextrin
Solubility
(in 100 cm3 solvent, at 25 °C)
Water: > 50 g
Methanol: < 0.5 g
Acetone: < 0.5 g
Specification
Test Method Range
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
Assay HPLC (USP <621>, EP 2.2.29) 95.0 - 105.0% on the anhydrous basis
Heavy metals ICP-MS (USP <232, 233> Cadmium  NMT 0.5 µg/g
Lead  NMT 0.5 µg/g
Arsenic  NMT 1.5 µg/g
Mercury  NMT 3.0 µg/g
Chromium  NMT 110 µg/g
Nickel  NMT 2 µg/g
Molybdenium  NMT 150 µg/g
Vanadium  NMT 1 µg/g
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) 525-700 μg/g
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) 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
Residual solvents: ethanol GC (USP <621>, EP 2.2.28) NMT 2500 ppm
pH (30%, w/V) USP <791> 4.0 - 6.8
Water content USP <921> Method I, EP 2.5.12 NMT 10.0 %
Storage: at room temperature, in tightly closed container.

MSDS Downloads

  • 47-SBECD

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