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

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Chemical and Physical Description

Average Molecular Formula	C₄₂H_70-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	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