Sulfobutylated beta-cyclodextrin sodium salt secondary standard

(CODE: -)

Price: € 115.76 / g

Abbreviation: SBECD

CAS Number: 182410-00-0

Product Number: -

Cyclodextrin type: Anionic cyclodextrins

Quality: analytical standard

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Volume	Volume Discount	Price
from 1 g	0%	€ 115.76 / g

Complies with EP and USP Pharmacopoeia requirements.

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

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)	t_R 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
Elemental impurities	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 %