Dexolve - Sulfobutylether-beta-cyclodextrin sodium salt (DS~6.5)

(CODE: 47)


Abbreviation: SBECD, Dexolve
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
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
tR 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

  • 47-SBECD

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