Sulfobutylated beta-cyclodextrin sodium salt

Min.Order / FOB Price:Get Latest Price

1 Kilogram	Negotiable

1 Kilogram

Negotiable

Min.Order :1 Kilogram
Purity: >95%, USP NF grade

Keywords

Captisol Dexolve SBECD

Quick Details

Appearance:white powder
Application:parenterals, oral formulations, solubilization, stabilization 182410-00-0
PackAge:
ProductionCapacity:|Metric Ton|Day
Storage:RT
Transportation:

Superiority:

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
Identification E	NMR (USP <761> EP 2.2.33)	Average Degree of Substitution: 5.9 - 6.6
Assay	HPLC (USP <621>, EP 2.2.29)	95.0 - 105.0% on the anhydrous basis
Heavy metals	EP 2.4.8 B	NMT 5 ppm
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)	125 - 300 μg/gd
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)	NMR (USP <761> EP 2.2.33)	5.9 - 6.6
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