SBE-β-CD CAS 182410-00-0 Betadex Sulfobutyl Eter Sodium Su'ega 95.0~105.0%

Betadex Sulfobutyl Eter Sodium
C42H70−nO35 · (C4H8SO3Na)n 2163 pe a n = 6.5
Beta cyclodextrin sulfobutyl eter, masima sodium;
Beta cyclodextrin sulfobutyl eter sodium [182410-00-0].
FAAMATALAGA
Betadex Sulfobutyl Eter Sodium ua saunia e ala i le alkylation o le betadex e faʻaaoga ai le 1,4-butane sultone i lalo o tulaga masani
Ole averesi tikeri ole sui ile betadex ole NLT 6.2 ma le NMT 6.9.
O lo'o i ai le NLT 95.0% ma le NMT 105.0% o le C42H70−nO35 · (C4H8SO3Na)n (n = 6.2-6.9), fa'atatau i le fa'avae anhydrous.
FAATINOGA
• A. FA'AULA'I FA'AULA'I <197K>
• B. O le taimi fa'atumauina o le tumutumu tele o le fofo Fa'ata'ita'i e fetaui ma le vaifofo masani, e pei ona maua i le Su'ega.
• I. E fa'amalieina mana'oga o le su'ega mo le Tulaga Fa'atatau o Suiga.
• D. SU'ESU'EGA FAATINO-A'OA'O, Sodium 〈191〉
SU'ESU'EGA
• TULAGA
Vaega feavea'i: 0.1 M potassium nitrate i se fa'afefiloi ole acetonitrile ma le vai (1:4)
Fofo masani: 10 mg / mL o le USP Betadex Sulfobutyl Ether Sodium RS i le vaega feaveaʻi
Fa'ata'ita'iga fofo: 10 mg/mL o le Betadex Sulfobutyl Eter Sodium i le vaega feavea'i
Faiga fa'akomepiuta
(Va'ai Chromatography <621>, Faiga Fa'atonu.)
Auala: LC
Su'esu'e: Fa'asinoga Fa'asino
Su'e vevela: 35 ± 2°
Koluma: 7.8-mm × 30-cm koluma su'esu'e;afifiina L37.[FAAMANATU- Fufulu le koluma i se vaifofo o le acetonitrile ma le vai (1:9) i le maeʻa ai o le faasologa.]
Fuafuaga tafe: 1.0 mL/min
Tele tui: 20 µL
Faiga talafeagai .
Fa'ata'ita'iga: Fofo masani
Mana'oga talafeagai
Feso'ota'iga tulaga ese: NMT 2.0%
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atatau le pasene ole betadex sulfobutyl eter sodium [C42H70−nO35 · (C4H8SO3Na)n] i le vaega ole Betadex Sulfobutyl Ether Sodium na ave:
I'uga = (rU/rS) × (CS/CU) × 100
rU = tali maualuga mo betadex sulfobutyl eter
sodium mai le Fa'ata'ita'i fofo
rS = tali maualuga mo betadex sulfobutyl eter
sodium mai le vaifofo masani
CS = faʻatonuga o le USP Betadex Sulfobutyl Eter
Sodium RS i le vaifofo masani (mg/mL)
CU = fa'atonuga o le Betadex Sulfobutyl Eter Sodium i le fa'ata'ita'iga fofo (mg/mL)
Tulaga taliaina: 95.0% ~ 105.0% i luga o le faʻavae anhydrous
LELEI
• METAL MAMAFA, Metotia II <231>: NMT 5 ppm
• TAULAGA O BETA CYCLODEXTRIN (BETADEX)
Fofo A: 25 mM sodium hydroxide
Fofo B: 250 mM sodium hydroxide ma 1 M potassium nitrate
Vaega feavea'i: Va'ai le Laulau 1.
Laulau 1

Fofo masani: 2 µg/mL o le USP Beta Cyclodextrin RS
Fa'ata'ita'iga fofo: 2 mg/mL o le Betadex Sulfobutyl Eter Sodium
Faiga fa'akomepiuta
(Va'ai Chromatography <621>, System Suitability and Ion Chromatography <1065>.)
Auala: IC
Su'esu'e: Amperometry pa'u (selau amperometric ma le eletise galue auro ma le eletise fa'amatalaga siliva)
Koluma
Leoleo: 4.0-mm × 5-cm anion-fetufaaiga;afifiina L61
Iloiloga: 4.0-mm × 25-cm anion-fetufaaiga;
afifiina L61
vevela o le koluma: 50 ± 2°
Fuafuaga tafe: 1.0 mL/min
Tele tui: 20 µL
Galue mo le pusi amperometric su'esu'e: Va'ai Laulau 2.
Laulau 2

Faiga talafeagai
Fa'ata'ita'iga: Fofo masani
Mana'oga talafeagai
Feso'ota'iga tulaga ese: NMT 5.0%
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atatau le pasene ole beta cyclodextrin (betadex) ile vaega ole Betadex Sulfobutyl Ether Sodium na ave:
I'uga = (rU/rS) × (CS/CU) × F × 100
rU = tali maualuga mo beta cyclodextrin mai le faʻataʻitaʻiga fofo
rS = tali maualuga mo beta cyclodextrin mai le vaifofo masani
CS = fa'asalaina ole USP Beta Cyclodextrin RS ile vaifofo masani (µg/mL)
CU = fa'atonuga o le Betadex Sulfobutyl Eter Sodium i le fa'ata'ita'iga fofo (mg/mL)
F = fa'aliliuga (10-3 mg/µg)
Ta'iala e talia: NMT 0.1%
• LIMIT O 1,4-BUTANE SULTONE
Fofo masani i totonu: 0.25 µg/mL o le diethyl sulfone
Fofo fa'asoa masani A: 0.5 µg/mL ole 1,4-butane sultone
Fofo masani fa'asoa B: 1.0 µg/mL ole 1,4-butane sultone
Fofo masani C: 2.0 µg/mL ole 1,4-butane sultone
Fa'ata'ita'iga vaifofo fa'asoa: 250 mg/mL o le Betadex Sulfobutyl Eter Sodium i totonu o le vaifofo masani fa'alotoifale.
Fofo avanoa, ma fa'ata'ita'iga fofo A, B, C, ma le D:
Mulimuli i le Fuafuaga 3 e tu'u ai le aofa'i o vaifofo fa'alotoifale, vaifofo fa'ata'ita'i ta'itasi, Fa'ata'ita'i vaifofo, vai, po'o le methylene chloride i totonu o ipu tioata ta'itasi ma se taofi.[FAAMANATU-E fetaui lelei le paipa su'esu'e 10-mL e ufiufi ai sikulu.] Faafefiloi i luga o se fa'afefiloi vortex paipa su'esu'e ta'itasi mo le 30 s, ma fa'ataga e tu mo le itiiti ifo i le 5 min pe se'ia mae'a le tu'ueseeseina o le vaega.Aveese le vaega faʻaola i totonu o se fagu GC ma faʻamaufaʻailoga.[FAATUATUA-Fa'aeteete ia ave le aofa'i aupito maualalo o le vaega vai.] Fa'aopoopo le aofa'i o le 1,4-butane sultone i Fa'ata'ita'i vaifofo A, B, C, ma le D e 0.5, 1.0, 2.0, ma le 0 µg.
Laulau 3

[FAMATALAGA-Sauni vave a o leʻi faʻaaogaina.]
Faiga fa'akomepiuta
(Va'ai Chromatography <621>, Faiga Fa'atonu.)
Auala: GC
Su'esu'e: Iona afi
Koluma: 0.32-mm × 25-m koluma fa'apipi'i-silica;0.5-µm vaega ole vaega G46
vevela
Su'esu'e: 270°
Tau tui: 200°
Koluma: Va'ai le polokalame vevela ile Laulau 4
Laulau 4
Vevela Muamua (°) Tempera Ramp (°/min) Vevela Mulimuli (°) Taimi Taofi ile Vevela Mulimuli (min)
100 10 200 -
200 35 270 5
Kesi ave: Helium, e masani lava ile 12 psi le mamafa o totonu
Tele tui: 1.0 µL
Ituaiga tui: tui le vaeluaina mo le 0.5 min, ona vaeluaina lea ile 50 mL/min.[FAAMANATU-E fautuaina le faʻaogaina o se tui tui e leai se vaeluaina.]
Faiga talafeagai
Fa'ata'ita'iga: Fa'ata'ita'iga fofo B
[FAAMATALAGA-O taimi faʻatatau mo le diethyl sulfone ma le 1,4-butane sultone e 0.7 ma le 1.0, faʻasologa.]
Mana'oga talafeagai
Feso'ota'iga tulaga ese: NMT 10.0%
Iloiloga
Fa'ata'ita'iga: Fofo avanoa, Fa'ata'ita'iga fofo A, B, C, ma le D
Fa'asa'o le fua o tali pito i luga o le 1,4-butane sultone i le diethyl sulfone i le fa'ata'ita'iga fofo A, B, C, po'o le D e ala i le toesea o le fua o tali pito i luga o le 1,4-butane sultone i le ethyl sulfone i le vaifofo Avanoa. .Fuafua le fua fa'asa'o ole tali pito i luga ole 1,4-butane sultone ile tali pito i luga ole diethyl sulfone ile fa'ata'ita'iga fofo A, B, C po'o le D, fa'atusatusa i le aofa'i fa'aopoopo, ile µg, ole 1,4-butane sultone.Fa'aopoopo le laina o lo'o so'o ai mata'itusi i luga o le kalafi se'ia fetaui ma le aofa'i axis.O le mamao i le va o lenei mata'itusi ma le va'aiga o to'i o lo'o fa'atusalia ai le aofa'i o le 1,4-butane sultone, A, i le µg, i le vaega 4-mL o Fa'ata'ita'iga fa'asoa vaifofo.Fuafua le anotusi o le 1,4-butane sultone i le vaega o le Betadex Sulfobutyl Ether Sodium na ave:
I'uga = A/(VExt × CU × F)
A = fuafuaina i luga
VExt = voluma o le vaifofo fa'ata'ita'i fa'ata'ita'iga na fa'aaogaina i le la'asaga o le fa'aaogaina, 4.0 mL
CU = fa'atonuga o le Betadex Sulfobutyl Eter Sodium i le fa'ata'ita'iga fa'asoa vaifofo (mg/mL)
F = fa'aliliuga (10-3 g/mg)
Tulaga talia: hydroxybutane-1-sulfonic acid, poʻo le NMT 0.5 ppm
• TAULAGA O LE SODIUM CHLORIDE, 4-HYDROXYBUTANE-1-SULFONIC ACID, MA BIS(4-SULFOBUTYL) ETER DISODIUM
Fofo A: 5 mM sodium hydroxide, degas i totonu o se va'a tapuni mo le 15 min
Fofo B: 25 mM sodium hydroxide, degas i totonu o se va'a tapuni mo le 15 min
Vaega feavea'i: Va'ai le Laulau 5
Laulau 5

Fofo mo le fufuluina o pou A: 50 mM sodium citrate
Fofo fufulu ile koluma B: 150 mM sodium hydroxide
Fofo masani: Saunia se vaifofo ua iloa le maualuga o le 8 μg/mL o le USP Sodium Chloride RS, 4μg/mL o le 4-hydroxybutane-1-sulfonic acid, ma le 4 μg/mL o le bis(4-sulfobutyl) eter disodium.
Fa'ata'ita'iga fofo: 4 mg/mL o le Betadex Sulfobutyl Eter Sodium
Faiga fa'akomepiuta
(Va'ai Chromatography <621>, System Suitability and Ion Chromatography <1065>.)
Auala: IC
Su'esu'e: Conductivity
Avanoa: 30 µS
Le taimi nei: 100 mA
Koluma: [FAATUATUA-I le faaiuga o ta'aloga ta'itasi, fa'amama le koluma e fa'aaoga ai le vaifofo fufulu Column A i le fua o le tafe o le 1 mL/min mo le 35 min ona fa'aaoga lea o le vaifofo fufulu Column B i le fua tutusa o le tafe mo le 35 min.]
Leoleo: 4.0-mm × 5.0-cm anion-fetufaaiga;afifiina L61
Iloiloga: 4.0-mm × 25-cm anion-fetufaaiga;afifiina L61
Vevela o le koluma: 30°
Suppressor: Micromembrane anion autosuppressor1 poʻo se faiga faʻagata talafeagai
Taofi: Autosuppression
Fuafuaga tafe: 1.0 mL/min
Tele tui: 20 µL
Faiga talafeagai
Fa'ata'ita'iga: Fofo masani
[FAATUATUA-Taimi fa'atumauina e tu'uina atu mo na'o fa'amatalaga.O taimi fa'amauina mo le 4-hydroxybutane-1-sulfonate ion, chloride ion, ma le bis(sulfobutyl) eter ion e 1.0, 1.4, ma le 8.6, fa'asologa.]
Mana'oga talafeagai
I'uga: NLT 2.0
Feso'ota'iga tulaga ese: NMT 10.0%
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atatau le pasene o le sodium chloride, 4-hydroxybutane-1-sulfonic acid, po'o le bis(sulfobutyl) ether disodium i le vaega ole Betadex Sulfobutyl Ether Sodium na ave:
I'uga = (rU/rS) × (CS/CU) × F × 100
rU = tali maualuga mo le sodium chloride, 4-hydroxybutane-1-sulfonic acid, poʻo le bis(sulfobutyl) eter disodium mai le faʻataʻitaʻiga fofo
rS = tali maualuga mo le sodium chloride, 4-hydroxybutane-1-sulfonic acid, poʻo le bis(sulfobutyl) eter disodium mai le vaifofo masani.
CS = fa'asalaina o le sodium chloride, 4-hydroxybutane-1-sulfonic acid, po'o le bis(sulfobutyl) eter disodium i le vaifofo masani (µg/mL)
CU = fa'atonuga o le Betadex Sulfobutyl Eter Sodium i le fa'ata'ita'iga fofo (mg/mL)
F = fa'aliliuga (10−3 0 100 0 mg/µg)
Tulaga taliaina
Sodium chloride: NMT 0.2%
4-Hydroxybutane-1-sulfonic acid: NMT 0.09%
Bis(sulfobutyl) eter disodium: NMT 0.05%
SU'E FA'AMANATU
SU'ESU'EGA ENDOTOXINS BACTERIAL <85>: Ole maualuga ole siama ole endotoxins e fa'amalieina le mana'oga i lalo ole fa'asologa talafeagai mo monokalafi lea e fa'aogaina ai le Betadex Sulfobutyl Eter Sodium e mafai ona ausia.Afai o loʻo taʻu mai e le igoa o le Betadex Sulfobutyl Ether Sodium e tatau ona faʻagasolo atili i le taimi o le sauniuniga o vailaʻau tui, o le maualuga o le endotoxins siama e pei o le manaʻoga i lalo o le faʻasologa talafeagai o monograph(s) lea e faʻaogaina ai le Betadex Sulfobutyl Ether Sodium. e mafai ona fetaui.
• SU'ESU'EGA FA'ATAUINA O MICROBIAL <61> ma SU'ESU'EGA MO FA'AMATALAGA FA'ASA'I <62>: Ole aofa'i ole aofa'i ole microbial e le sili atu ile 100 cfu/g, ma le aofa'i ole aofa'i o limu ma fefete e le sili atu ile 50 cfu/g.E fetaui ma manaʻoga o le suʻega mo le leai o Escherichia coli.
• MANINO O FOFO
Fa'ata'ita'iga fofo: 30% (w/v) fofo
Su'esu'ega: Su'esu'e le Fa'ata'ita'i fofo e fa'aaoga ai se atigipusa moli e fa'asaga i tua papa'e ma uliuli, ma fa'amaumau le iai o so'o se pua'a, fa'amalama, alava, specks, po'o isi mea mai fafo.
Tulaga talia: E manino le fofo, ma e matua saoloto lava mai vaega o mea mai fafo.
• FAATAU TATAU O LE SUI
Fa'amalo eletise: 30 mM benzoic acid ma fetuutuunai i se pH e talafeagai mo le mea faigaluega faʻaaogaina e ala i le faʻaopoopoina o le 100 mM tris(hydroxymethyl) aminomethane buffer.
[FAAMANATU-Ona o fesuiaiga i le va o capillaries, e tasi le pH electrolyte talafeagai e le o faamaotiina.
Nai lo lena, o le pH sili ona lelei e fesoʻotaʻi ma capillary taʻitasi e tatau ona fuafua e tusa ai ma le tusi lesona meafaigaluega.]
Fofo masani: 10 mg/mL o le USP Betadex Sulfobutyl Eter Sodium RS
Fa'ata'ita'iga fofo: 10 mg/mL o le Betadex Sulfobutyl Eter Sodium
Fa'asologa o le fufuluina o le capillary: Fa'aaogā fagu fa'aeletise ta'avale eseese mo le fufulu fa'apalapala ma fa'ata'ita'iga su'esu'ega.Fa'atino vaimama i aso ta'itasi a'o le'i faia su'esu'ega ta'itasi: fufulu le capillary ile 0.1 N sodium hydroxide mo le 30 min, ile vai mo le NLT 2 h, ma le Run electrolyte mo le NLT 1 h.Fa'atino vaimama a'o le'i tui ta'itasi e pei ona ta'ua i lalo.Fufulu le capillary i le 0.1 N sodium hydroxide mo NLT 1 min, ma faʻatasi ma le electrolyte Run mo NLT 3 min.Afai o loʻo faʻaaogaina se capillary fou, faʻaopoopo i vaimama masani o loʻo faʻamatalaina i luga, e manaʻomia e le capillary fou le fufulu aʻo leʻi faʻaaogaina muamua.Fufulu le capillary fou i le 1 M sodium hydroxide mo le 1 itula, sosoo ai ma le 2-itula fufulu vai.
Faiga eletise
(Taga'i Capillary Electrophoresis <1053>.)
Faiga: maualuga-fa'atinoga CE
Su'esu'e: Fa'asaga i le UV 200 nm, fa'atasi ai ma le bandwidth o le 20nm.[FAAMATALAGA-E mafai ona faʻaaogaina le umi ole galu ole 205 nm ma se bandwidth ole 10 nm e fai ma sui.]
Koluma: Sodium Peaks I–X (% Peak Area) 50-µm × 50-cm koluma silika fusifusia
Vevela o le koluma: 25°
Voliti fa'aogaina: 0.00 i le +30.00 kV laina laina i luga ole 10 min, ona i ai lea ile 30 kV mo se isi 20 min.
Tele ole tui: Tutusa voluma ile 0.5 psi mo le 10 s
Faiga talafeagai
Fa'ata'ita'iga: Fofo masani
[FAATUATUA-Va'ai le Laulau 6 mo taimi femalaga'iga fa'atatau mo betadex sulfobutyl ether sodium peaks I-X (betadex sulfobutyl ether sodium peaks I, II, III, ..., X, o lo'o i ai mole mole beta cyclodextrin ma le 1, 2, 3, ..., 10 sulfobutyl substituent(s), faasologa).Ole taimi ole femalaga'iga e mo na'o fa'amatalaga fa'amatalaga e fesoasoani ai ile fa'ailoa maualuga.]
Laulau 6

Mana'oga talafeagai
I'uga: NLT 0.9, i le va o le betadex sulfobuty eter sodium peak IX ma le betadex sulfobutyl eter sodium peak X
Iloiloga
Fa'ata'ita'iga: Fa'amalo eletise, vai, Fofo masani, ma fa'ata'ita'iga fofo
Tu'i le vaifofo Fa'ata'ita'i ma Fa'ata'ita'iga fofo e ala i le fa'aogaina o le mamafa o le 0.5 psi, e tutusa ma le 34 mbar, mo le 10 s, sosoo ai ma le tui ole Run electrolyte ile 0.5 psi mo le 2 s.[FAAMANATU-O tui e tatau ona faia i se fagu vai poʻo le eletise eletise i le pito pito i fafo o le capillary.]
Faamaumau le electropherograms, ma fua le maualuga o tali mo le betadex sulfobutyl ether sodium peaks (I i le X).Fa'atatau le vaega pito i luga ole laiga, AI, mo tumutumu ta'itasi ile eletropherogram:
Fa'asa'o le Peak Area A = Peak Area x Lelei Capillary Umi (cm) / Taimi Femalagaa'i
Fa'asa'o vaega pito i luga e ala i le tu'uina atu o vaega ta'itasi o se pasene o le aofa'i o le vaega o teutusi sui fa'asa'o:
Avanoa Fa'aigoa, NA: A / n∑i=1 Ai x 100
n = maualuga maualuga o le suitulaga
Fuafua le maualuga o le suitulaga:
Tulaga Fa'atatau o Suiga = n∑i=1 (Tulaga o Suiga mo le Peak x NA) / 100
Tulaga taliaina: 6.2~6.9 mo le tikeri averesi o le suitulaga
Mo ta'itasi ole betadex sulfobutyl ether sodium peaks I-X, va'ai le laina tapula'a (% o le pito maualuga) ile Laulau 7.
Laulau 7

• PH <791>: 4.0-6.8, i totonu o se vaifofo 30% (w/v) i le vai e leai se kaponi
• FA'IFUAINA O LE SUAI, Metotia I <921>: NMT 10.0%
FAAOPOOPOGA
• FA'A'U'U MA TE'UINA: Fa'asao i totonu o pusa tapuni lelei, ma teu i le potu vevela.Puipui mai le susu.
• LABELING: Fa'aigoa e fa'ailoa ai lona fa'aogaina i le gaosiga o vaila'au tui.
• USP REFERENCE STANDARD <11>
USP Beta Cyclodextrin RS
USP Betadex Sulfobutyl Eter Sodium RS
USP Endotoxin RS
USP Sodium Chloride RS■1S (NF30)