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Dexolve - Sulfobutylether-beta-cyclodextrin sodium salt (DS~6.5)
(CODE: 47)
Abbreviation:
SBECD, Dexolve
CAS Number:
182410-00-0
Product Number:
47
Cyclodextrin type:
Randomly substituted, anionic
Quality:
Pharma grade
for
2 450.00
EUR
Get a quote
Chemical and Physical Description
Average Molecular Formula
C
42
H
70-n
O
35
· (C
4
H
8
O
3
SNa)
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 cm
3
solvent, at 25 °C)
Water: > 50 g
Methanol: < 0.5 g
Acetone: < 0.5 g
Specification
Storage:
at room temperature, in tightly closed container.
Test
Method
Specification
Appearance* #
visual
white or off-white,powder
Identification A
IR; USP <197K>, EP 2.2.24
complies with SBECD reference
Identification B (Assay method)
HPLC
USP <621>, EP 2.2.29
t
R
of major peak complies with SBECD reference
Identification C
CE; USP <1053>
NMR
USP <761> EP 2.2.33
Meets the requirement of average degree of substitution
Identification D
Sodium ID; USP <191>, EP 2.3.1
positive test for sodium
Assay #
HPLC; USP <621>, EP 2.2.30
95.0-105.0 % on the anhydrous basis
Heavy metals
ICP-MS,
USP <232,233>
Cadmium NMT 0.2 µg/g
Lead NMT 0.5 µg/g
Arsenic NMT 1.5 µg/g
Mercury NMT 0.3 µg/g
Chromium NMT 110 µg/g
Nickel NMT 2 µg/g
Molybdenum NMT 150 µg/g
Vanadium NMT 1 µg/g
Cobalt NMT 0.1 µg/g
Limit of Beta Cyclodextrin
(Betadex) #
HPLC;
USP <621>
NMT 0.1 % on the anhydrous basis
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>, EP 2.4.4
NMT 0.2 %
Limit of 4-Hydroxybutane-1-sulfonic Acid
CE; USP <1053>
NMT 0.09 %
Limit of Bis(4-sulfobutyl) Ether Disodium
CE; USP <1053>
NMT 0.05 %
Bacterial Endotoxin Test #
USP <85>, EP 2.6.14
≤ 24 IU/g
Microbial Enumeration Tests #
USP <61>, EP 2.6.12
TAMC ≤ 100 CFU/g;
TYMC ≤ 50 CFU/g
* No requirements are given in USP -NF for appearance and limits of cyclodextrin related substances
# To be performed in stability study
Test
Method
Specification
Test for Specified Microorganism
USP <62>, EP 2.6.13
absence of Escherichia Coli /1 g
absence of Salmonella /10 g
Clarity of solution (30%, w/v) #
visual, see details in the USP NF Monograph, EP 2.2.1
the solution is clear, and essentially free from particles of foreign matter
Clarity of solution (15%, w/v) #
visual, EP 2.2.1 and
2.2.2 (Method II)
the solution is clear and colorless
pH (30%, w/v) #
USP <791>
4.0 – 6.8
Phosphate content
UV-VIS
USP <857>, EP 2.2.25
525-700 μg/g
Average Degree of Substitution [DS]
NMR; EP 2.2.33
5.9 – 6.6
Average Degree of Substitution [DS]
CE; USP <1053>
6.2 – 6.9
Peak distribution
CE; USP <1053>
Each SBECD peak (I-X) meets the limit range (peak area %) of the Monograph
SBECD sodium peaks
Limit range
(% 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
VIII (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 (15%, w/v) #
EP 2.2.3
5.0-7.5
Water Content #
USP Method I <921>, EP 2.5.12
NMT 10.0 %
Impurities
IMP A (BCD)
IMP C (HOBSA)
IMP D (DIBSA)
HPLC
EP 2.2.29
NMT 0.1%
NMT 0.1%
NMT 0.05%
IMP B (Limit of 1,4-Butane Sultone)
GC, EP 2.2.28
NMT 0.5 ppm
Reducing sugar
UV VIS; EP 2.2.25
NMT 0.05%
* No requirements are given in USP -NF for content of residual solvents (ethanol); # To be performed in stability study
Packaging and Storage: Preserve in well-closed containers, store at room temperature. Protect from moisture.
Labelling: indicate its use in the manufacture of injectable dosage forms.
MSDS Downloads
MSDS_CY_2041_SBECDv3.7
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