SBE-β-CD CAS 182410-00-0 Betadex Sulfobutyl Ether Sodium Assay 95.0~ 105.0%

Description:

Betadex Sulfobutyl Ether Sodium

Synonyma: SBE-β-CD

CAS: 182410-00-0

Ingrediatur: 95.0~ 105.0%

Albus vel Fere albus Amorphous Pulvis

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Ruifu Chemical fabrica princeps est Betadex Sulfobutyl Ether Sodium (SBE-β-CD; Captisol) (CAS: 182410-00-0) magna qualitate.Ruifu partus terrarum, pretium auctorum, servitium praestans, parvae quantitatis et quantitatis in promptu, potest praebere.Purchase Betadex Sulfobutyl Ether Sodium,Please contact: alvin@ruifuchem.com

Chemical Properties:

Nomen chemicum Betadex Sulfobutyl Ether Sodium
Synonyma SBE-β-CD;SBE-beta-CD;Captisol;Sodium Sulfobutylether β-Cyclodextrin;Sodium Sulphobutylether-beta-Cyclodextrin;Sulfobutylether beta-Cyclodextrin;Beta-Cyclodextrin Sulfobutyl Ethers Sodium Salts;β-Cyclodextrin Sulfobutyl Ethers Sodium Salts
Stock Status In Stock, Commercial Productio
CAS Number 182410-00-0
Formulae hypotheticae C42H70O35•xNa•x(C4H9O3S)
M. Pondus (1134.99).x(22.99).x (137.17) g/mol
Liquescens punctum 202.0~204.0℃(dec.)
Solubilitas Solutum in aqua.Insolubilis in Acetone, Methanolo, Chloroformi
HS Code* 350510000
COA & MSDS Praesto
Sample Praesto
Origin Shanghai, China
Brand Ruifu Chemical

Specifications:

Items Signa inspectionis Proventus
Aspectus Alba ad Off-White Amorphoum pulveris Conformare
Lepidium sativum IR Eadem effusio vincula ut USP Betadex Sulfobutyl Ether Sodium RS Conformare
Lepidium sativum HPLC Retentionis tempus solutionis maioris specimen apicem solutioni mensurae respondet Conformare
Mediocris gradus substitutionis Conformare Conformare
Sodium sativum COGNOSCO test positivum pro Sodium Conformare
Assay 95.0%~ 105.0% 99.49%
Beta Cyclodextrin ≤0.10% Non Results
1,4-Butane Sultone ≤0.5ppm 0.19ppm
Sodium chloride ≤0.20% 0.003%
4-Hydroxybutane-1-Sulfonic Acid ≤0.09% Non Results
Bis(4-Sulfobtyl) Aether Disodium ≤0.05% Non Results
Bacterial Endotoxins ≤20EU/g <5EU/g
Summa Aerobic Microbial Comitis ≤100cfu/g* <10cfu/g
Totalis deducta fingit et Yeasts Comitis ≤50cfu/g* <10cfu/g
Mus absentia Non Results
Solutio in claritate 30% (w/v) Solutio manifesta et essentialiter libera a particulis materiae alienae. Conformare
Mediocris gradus substitutionis 6.2~6.9 6.5
Apicem I 0.0~0.3 0
Apicem II 0.0~0.9 0.62
Apicem III 0.5~5.0 1.41
Apicem IV 2.0~10.0 4.46
Apicem V 10.0~20.0 11.72
Apicem VI 15.0~25.0 20.75
Apicem VII 20.0~30.0 29.04
Apicem VIII 10.0~25.0 21.59
PeakI X * 2.0~12.0 7.83
Apicem X* 0.0~4.0 2.57
pH 4.0~6.8 4.8
Aqua Content ≤10.0% 4.9%
Infrared Imaginis Conformat ut Structure Obsequitur
conclusio Hoc productum per inspectionem secundum mensuram USP35

Sarcina / at /naviportans:

Sarcina:Utrem, aluminium foil, sacculum, 25kg/cardboard Drum, vel secundum exigentiam emptoris.
Repono Condition:Serva in vasis bene clausis et in loco frigido, sicco (2~8℃) conservato et in horreis bene ventilatis a substantiis incompossibilibus.A luce et humore protege.
Naviportans:Libera ad mundum ab aere, per FedEx / DHL Express.Ieiunium et certas traditiones provide.

182410-00-0 - USP35 Latin:

Betadex Sulfobutyl Ether Sodium
C42H70−nO35 · (C4H8SO3Na)n 2163 quando n = 6.5
Beta cyclodextrin sulfobutyl aetherea, salia natrii;
Beta cyclodextrin sulfobutyl aethereum sodium [182410-00-0].
DEFINITIO
Betadex Sulfobutyl Ether Sodium praeparatur ab alkylatione betadex utens 1,4-butane sultone sub elementis fundamentalibus.
Mediocris gradus substitutionis in betadex NLT 6.2 et NMT 6.9.
Continet NLT 95.0% et NMT 105.0% C42H70−nO35 · (C4H8SO3Na)n (n = 6.2-6.9), in fundamento anhydroso computatum.
IDENTIFICATIO
• A. ABSORPTION INFRARED <197K>
• B. Retentionis tempus solutionis maioris partis Sample respondet solutioni mensurae, prout habetur in Assay.
• C. Occurrit requisitis testi pro Mediocris Degree Substitutionis.
• D. IDENTIFICATIO TESTIMONIORUM GENERALIS, Sodium 〈191〉.
TEMPTATIO
• MODO PROCEDENDI
Mobilis pars: 0.1 M nitrate potassii in mixtione acetonitrili et aquae (1:4).
Solutio mensurae: 10 mg/mL de USP Betadex Sulfobutyl Ether Sodium RS in tempore Mobili
Sample solutio: 10 mg/mL de Betadex Sulfobutyl Ether Sodium in tempore Mobili
Systema chromatographicum
(Vide Chromatographiam <621>, Ratio idoneitatis.)
Modus: LC
Detector: Refractivus index
Detector temperatus: 35 ± 2°
Columna: 7.8-mm 30-cm columna analytica;stipare L37.[NOTA-Rusa columna cum solutione acetonitrili et aquae (1:9) ad complementum seriei currentis.]
Fluunt rate: 1.0 mL/min
Iniectio amplitudo: 20 µL
Ratio convenientia.
Sample: Latin solution
Convenientia requisita
Relativum vexillum declinationis: NMT 2.0%
Analysis
Exempla: Standard solution et Sample solutionem
Recipis betadex sulfobutyl et sodium [C42H70−nO35 · (C4H8SO3Na)n] in portione Betadex Sulfobutyl Ether Sodium sumpti;
Proventus = (rU/rS) (CS/CU) 100
rU = apicem responsio ad betadex sulfobutyl ether
sodium ex Sample solutione
rS = apicem responsio ad betadex sulfobutyl aether
sodium ex solutione Latin
CS = intentio USP Betadex Sulfobutyl Ether
Sodium RS in solutione Standard (mg/mL)
CU = intentio Betadex Sulfobutyl Ether Sodium in Sample solutione (mg/mL)
Criteria acceptationis: 95.0%~ 105.0% in anhydrous fundamento
IMPURITIES
• METALS GRAVIUS, Methodus II <231>: NMT 5 ppm .
• FINIS BETA CYCLODEXTRIN (BETADEX)
Solutio A: 25 mM sodium hydroxidum
Solutio B: 250 mM sodium hydroxidum et 1 M potassae nitrate
Mobile phase: See Table 1 .
Table 1

Tempus (min) Solutio A (%) Solutio B (%)
0 100 0
4 100 0
5 0 100
10 0 100
11 100 0
20 100 0

Solutio Standard: 2 µg/mL of USP Beta Cyclodextrin RS
Sample solutio: 2 mg/mL de Betadex Sulfobutyl Ether Sodium
Systema chromatographicum
(Vide Chromatographiam <621>, Systema Idoneum et Ion Chromatographia <1065>).
Modus: IC
Detector: Pulsed amperometria (cellula amperometrica et aurum operantes electrode et argentum electrode referat)
Columna
Cohortis: 4.0-mm × 5-cm anion-commutatio;stipare L61
Analytica: 4.0-mm × 25-cm anion-commutatio;
stipare L61
Columna temperatus: 50 ± 2°
Fluunt rate: 1.0 mL/min
Iniectio amplitudo: 20 µL
Waveform pro pulsibus amperometricis detectis: vide Tabula II.
Table 2

Tempus (s) Voltage (V)
0.00 0.10
0.30 Initium integrationis
0.50 0.10
0.50 Subsisto integration
0.51 0.60
0.60 -0.60
0.65 -0.60

Ratio convenientia
Sample: Latin solution
Convenientia requisita
Relativum vexillum declinationis: NMT 5.0%
Analysis
Exempla: Standard solution et Sample solutionem
Recipis beta cyclodextrin (betadex) in portione Betadex Sulfobutyl Ether Sodium sumpti;
Proventus = (rU/rS) (CS/CU) F 100
rU = apicem responsionis pro beta cyclodextrin ex Sample solutione
rS = apicem responsio pro beta cyclodextrin ex solutione Standard
CS = intentio USP Beta Cyclodextrin RS in solutione Standard (μg/mL)
CU = intentio Betadex Sulfobutyl Ether Sodium in Sample solutione (mg/mL)
F = factor conversionis (10-3 mg/µg)
Acceptatio criteria: NMT 0.1%
• FINIS 1,4-BUTANE SULTONE
Solutio mensurae internae: 0.25 µg/mL sulfonis diethyl
Solutio generum stirpis A: 0.5 µg/mL of 1,4-butaneorum sultone
Solutio generum stirpis B: 1.0 µg/mL of 1,4-butaneorum sultone
Solutio generum stirpis C: 2.0 µg/mL of 1,4-butaneorum sultone
Sample solutionis stirpis: 250 mg/mL de Betadex Sulfobutyl Ether Sodium in solutione normae internae
Solutio blank, et solutiones Samples A, B, C, D;
Sequere Tabula 3 ut solutionem normae internae quantitates ponas, unaquaeque solutio generum stirpis, Sample solutionis stirpis, aquae vel chloridi methyleni in singulis tubulis vitreis cum spissamentum.[Nota cochleae capped, 10-mL tubus testium aptus est.] Misce in vortice mixer unumquemque tubulum testium pro 30 s, et stare permitte ad minimum 5 min vel usque ad integram separationem Phase.Extraho organicum phase in GC phialam et sigillum.[NOTA-Quamquam minimam quantitatem aquei temporis magna diligentia adhibemus.] Additae quantitates 1,4-butanei sultoni in solutionibus Samples A, B, C, D sunt 0.5, 1.0, 2.0, et 0 µg, respective.
Table 3

Sample Name Solutio 1 Additur (mL) Solutio 2 Addatur (mL) Methylene Chloride Added (mL)
blank solution Solutio mensurae internae, 4.0 Aquae, 1.0 1.0
Sample solutio A Sample stirpe solutio, 4.0 Standard stock solution A, 1.0 1.0
Sample solutio B Sample stirpe solutio, 4.0 Standard stock solution B, 1.0 1.0
Sample solutio C Sample stirpe solutio, 4.0 Standard stock solution C, 1.0 1.0
Sample solutio D Sample stirpe solutio, 4.0 Aquae, 1.0 1.0

[Nota statim ante usum para.]
Systema chromatographicum
(Vide Chromatographiam <621>, Ratio idoneitatis.)
Modus: GC
Detector: flamma ionization
Columna: 0.32-mm 25-m columna capillari-silica fuscata;0.5-µm tabulatum periodicum G46
Temperature
Detector: 270°
Iniectio port: 200°
Columna: Vide programmata temperatura in Tabula 4
Table 4
Coepi Temperature (°) Temperature Ramp (°/min) Temperature Final (°) Temperature in Final Temperature (min)
100 10 200 -
200 XXXV 270 5
Portitorem gas: Helium, fere ad 12 psi limbum pressionis
Magnitudo iniectio: 1.0 µL
Iniectio generis: iniectio Splitless pro 0,5 min, tunc finditur in 50 mL/min.[Nota-Usus congrui injectionis splitless commendatur.]
Ratio convenientia
Sample: Sample solutio B
[NOTA-Retentio relativa tempora sulfonis diethyl et 1,4-butanei sultonis sunt 0.7 et 1.0, respective.].
Convenientia requisita
Relativum vexillum declinationis: NMT 10.0%
Analysis
Exempla: solutionem Blank, solutiones Samples A, B, C, D
Recta ratio cacumina responsionum 1,4-butaneorum sulfonis diethyl in solutione A, B, C, vel D, subtrahendo rationem cacumina responsionum 1,4-butaneorum sultonum ad ethyl sulfonis in solutione Blank. .Insidiari rectam rationem cacuminis responsionis 1,4-butanei sultonis ad apicem responsionis sulfonis diethyl in solutione A, B, C vel D, versus quantitatem additae, in µg, sultonis 1,4-butanei.Extrahe lineam punctis graphi iungentem, donec occurrat axis quantitati.Distantia inter hoc punctum et axium intersectionem quantitatem sultonis 1,4-butanei, A, in µg, in 4-mL portionis Samplei generis solutionem repraesentat.Computus contentum sultoni 1,4-butanei in portione Betadex Sulfobutyl Ether Sodium sumptum:
Proventus = A/(VExt CU F)
A = determinatum est
VExt = volumen solutionis de sample stirpes in gradatim extractione adhibitae, 4.0 mL .
CU = intentio Betadex Sulfobutyl Ether Sodium in Sample stirpe solutio (mg/mL)
F = factor conversionis (10-3 g/mg)
Re- gulae acceptationis: acidum hydroxybutanum-1-sulfonicum, seu NMT 0.5 ppm
• FINIS SODII CHLORIDIS, 4-HYDROXYBUTANE-I-SULFONICI ACIDUM, ET BIS (4-SULFOBUTYL) AETHER DISODIUM.
Solutio A: 5 mM sodium hydroxidum degas in vase clauso pro 15 min
Solutio B: 25 mM sodium hydroxidum degas in vase clauso pro 15 min
Mobile phase: See Table 5
Table 5

Tempus (min) Solutio A (%) Solutio B(%)
0 100 0
4 100 0
10 70 30
24 70 30
25 100 0
40 100 0

Columna lava solutio A: 50 mM sodium citratum
Columna lava solutio B: 150 mM sodium hydroxidum
Solutio Vulgata: Para solutionem habentes concentrationes notarum 8 µg/mL of USP Sodium Chloride RS, 4µg/mL acidi 4-hydroxybutani-1-sulfonici, et 4 µg/mL ex bis (4-sulfobutyl) aetheris disodium.
Sample solutio: 4 mg/mL de Betadex Sulfobutyl Ether Sodium
Systema chromatographicum
(Vide Chromatographiam <621>, Systema Idoneum et Ion Chromatographia <1065>).
Modus: IC
Detector: Conductivity
Range: 30 µS
Current: 100 mA
Columna: [NOTA-In fine cuiusque currendi, columna munda utens Columna lava solutionem A ad profluentem rate of 1 mL/min pro 35 min tunc utens Columna lava solutionem B ad eandem ratem fluxus pro 35 min.]
Custodi: 4.0-mm × 5.0-cm anion-commutatio;stipare L61
Analytica: 4.0-mm × 25-cm anion-commutatio;stipare L61
Columna temperatus: 30°
Suppressor: Micromembrana anion autosuppressor1 vel ratio chemicae suppressionis idonea
Suppressus: Autosuppression
Fluunt rate: 1.0 mL/min
Iniectio amplitudo: 20 µL
Ratio convenientia
Sample: Latin solution
[Nota retentio relativa tempora solum informationibus providentur.Tempora relativa retentio pro 4-hydroxybutano 1-sulfonato ion, ion chloride, et bis (sulfobutyl) aether ion sunt 1.0, 1.4, et 8.6, respective.]
Convenientia requisita
Resolutio: NLT 2.0
Relativum vexillum declinationis: NMT 10.0%
Analysis
Exempla: Standard solution et Sample solutionem
Recipis sodium chloridum, 4-hydroxybutanum 1-sulfonicum, vel bis (sulfobutyl) aetherem disodium in portione Betadex Sulfobutyl Ether Sodium sumptum;
Proventus = (rU/rS) (CS/CU) F 100
rU = apicem responsionis ad sodium chloridum, 4-hydroxybutanum 1-sulfonicum, seu bis (sulfobutyl) aetheris disodium ex solutione Sampli.
rS = apicem responsionis ad sodium chloridum, 4-hydroxybutanum-I-sulfonicum, seu bis (sulfobutyl) aetheris disodium ex solutione Vulgatae.
CS = concentratio sodii chloridi, 4-hydroxybutanei 1-sulfonici, vel bis (sulfobutyl) aetheris disodium in solutione Standard (µg/mL)
CU = intentio Betadex Sulfobutyl Ether Sodium in Sample solutione (mg/mL)
F = factor conversionis (10−3 0 100 0 mg/µg)
Criteria acceptatio
Sodium chloridum: NMT 0.2%
4-Acidi hydroxybutanei-sulfonici: NMT 0.09%
Bis (sulfobutyl) aether disodium: NMT 0.05%
IN SPECIE TESTS
BACTERIALIS ENDOTOXINS TEST <85>: Bacteria endotoxorum planities talis est ut exigentia sub specie dosis monographiae (s) in qua Betadex Sulfobutyl Ether Sodium adhibitus occurri potest.Ubi titulus affirmat Betadex Sulfobutyl Ether Sodium ulteriori processui subiici debere in praeparatione formarum injectabilium dosis, endotoxiorum bacterial planities talis est ut exigentia sub tali forma dosis monographo(s) in qua Betadex Sulfobutyl Ether Sodium adhibetur. occurri potest.
• MICROBIALIS ENUMERATIO TESTIUM <61> et probat MICROORGANISMORUM SPECIFIED <62>: Tota aerobica microbialis computatio 100 cfu/g non excedit, et formas compositas et fermentationes summam computationem 50 cfu/g non excedit.Occurrit requisitis ab- tium Escherichia coll.
• Solutio in claritate
Sample solutio: 30% (w/v) solution
Analysis: Exemplar solutionem examinare utens capsulae lucis contra backgrounds albis et nigris, et praesentiam cuiusvis obductus, fluorescentiae, fibrarum, floccorum, aliarumve materiarum exterarum notare.
Re- gulae acceptationis: Solutio manifesta, et per se immunis a particulis materiae exterae.
• MEDIUM INTER GRADUS substitutionis
Currite electrolytici: 30 mM acidum benzoicum et ad pH accommodatum instrumento adhibito, additamento 100 mM tris (hydroxymethyli) quiddam aminomethani accommodatum.
[Nota-Ob variationem inter capillarias electrolytici pH universaliter unum locum non specificatur.
Potius, optimalis pH cum singulis capillaribus coniungendis secundum manualem instrumentalem determinari debet.]
Solutio mensurae: 10 mg/mL de USP Betadex Sulfobutyl Ether Sodium RS
Sample solutio: 10 mg/mL de Betadex Sulfobutyl Ether Sodium
Procedure lotis capillaris: Utere phialas electrolyticae separatas pro stupo capillari et analysi sample.Prae-analysin lavare cottidie ante singulas analysin fac: eluo capillarium cum 0.1 N hydroxide sodium pro 30 min, cum aqua pro NLT 2 h, et cum curre electrolytici pro NLT 1 h.Praeeminentia lavat ante quamlibet iniectio sic facite.Intus capillarium cum 0.1 N sodium hydroxidum pro NLT 1 min, et cum electrolytico Curre pro NLT 3 min.Si nova capillaria adhibeatur, praeter lavationes regulares de quibus supra dictum est, nova capillaris lotio ante primum usum requirit.Inusse capillarium novum cum 1 M sodium hydroxidum pro 1 h, sequitur aqua 2-h rinse.
Systema electronicum
(Vide Electrophoresis Capillaris <1053>).
Modus: summus perficientur CE
Detector: Inverse UV 200 um, cum band 20nm.[NOTA-A deprehensio necem 205 um cum sede 10 nm joco adhiberi potest.]
Columna: Sodium Peaks I-X (% Area Peak) 50-µm × 50-cm columna silica conflata.
Columna temperatus: 25°
Applicata intentione: 0.00 ad +30.00 kv, aggerem linearem supra 10 min, deinde ad 30 kv pro amplius 20 min.
Iniectio size: Aequalia volumina 0.5 psi pro 10 s
Ratio convenientia
Sample: Latin solution
[NOTA-See Tabula VI temporibus migrationis relativae approximatis pro betadex sulfobutylo vel sodium cacumina I-X (betadex sulfobutyl vel sodium cacumina I, II, III, ..., X, continet beta cyclodextrinum moleculum cum 1, 2, 3, ..., 10 sulfobutyl substituent(s), respective).Migratio relativa tempora sunt ad proposita informationales tantum ad auxilium in apicem cognitionis.
Table 6

Betadex Sulfobutyl Ether Sodium cacumina I-X Donec adipiscing tempus
ego 0.58
II 0.63
III 0.69
IV 0.77
V 0.83
VI 0.91
VII 1.00
VIII 1.10
IX 1.20
X 1.30

Convenientia requisita
Resolutio: NLT 0,9, inter betadex sulfobuty, inter aetherem sodium apicem IX et betadex sulfobutyl, aethere sodium apicem X.
Analysis
Exempla: Currite electrolytici, aquae, solutionis Standardi, et solutionis Sample
Inject solutionem Standard et solutionem Sample applicando pressionis differentialis 0.5 psi, aequivalens 34 mbar, pro 10 s, sequitur iniectio electrolytici Rufi ad 0.5 psi pro 2 s.[Notae-Pressurae injectiones fiendae cum ampulla aquae vel currendi electrolytici ad exitum capillaris exitu.
Electropherogramma notare, et cacumen responsiones metire pro singulis betadex sulfobutyli vel sodii cacumina (I ad X).Apicalem apicem aream correctam, AI, ad utrumque apicem in eletropherogramme;
Area A Corrigenda Pecco = Pecco Area x Capillaris Longitudo efficax (cm) / Donec adipiscing tempus
Normalize emendata apicem areas exhibens singulas recipis totalis emendatae substitutionis involucro regio:
Nomalized Area, NA: A/n∑i=1 Ai x 100
n = supremo gradu substitutionis
Determinare mediocris gradus substitutionis;
Mediocris gradus substitutionis = n∑i=1 (Level substitutionis pro Pecco x NA) / 100
Acceptatio criteria: 6.2~6.9 pro mediocris gradus substitutionis
Uterque betadex sulfobutyl vel sodium cacumina I-X, vide limitem range (% area apicem) in Tabula VII.
Table 7

Betadex Sulfobutyl Ether Sodium cacumina I-X Finis dolor (% Pecco Area)
I 0-0.3
II 0-0.9
III 0.5-5.0
IV 2.0-10.0
V 10.0-20.0
VI 15.0-25.0
VII 20.0-30
VIII 10.0-25.0
IX 2.0-12.0
X 0-4.0

• PH <791>: 4.0-6.8, in 30% (w/v) solutio in aqua dioxide-libero.
• AQUA BENEDICTA, Ratio I <921>: NMT 10.0%
ADDITICIUS REQUISITIS
• PACKAGING et Repono: Conserva in vasis bene clausis et in cella temperatura repone.Ab humore protege.
• LABELING: Label ad indicandum usum in fabricandis formis injectabilium dosis.
• USP Reference STANDARDS <11>
USP Beta Cyclodextrin RS
USP Betadex Sulfobutyl Ether Sodium RS
USP Endotoxin RS
USP Sodium Chloride RS■1S (NF30)

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Ieiunium Delivery: Si intra stirpem, tres dies partus praestatur

Supple firmum: Esse rationabile stirpe

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182410-00-0 - Applicatio:

Betadex Sulfobutyl Ether Sodium (SBE-β-CD; Captisol) (CAS: 182410-00-0) novum genus est cyclodextrinum chemicae modificatum cum structura ad optimizandam solutionem et stabilitatem medicamentorum.

Betadex Sulfobutyl Ether Sodium novum genus praeparationis pharmaceuticae est exceptum, quod ad acidum sulfonicum derivatum cyclodextrinum anionicum valde aquaticum.Bene coniungi cum moleculis medicamento potest ad complexiones non covalentes formandas, quae stabilitatem, aquam solubilitatem, et salutem medicamentorum meliorem efficiunt, et efficaciter emendare actionem biologicam pharmaci moleculi.Nephrotoxicitas eius parva est, et medicamentum hemolysin sublevare potest., medicamento remissionis rate temperare.

Betadex Sulfobutyl Aether Sodium formare potest complexiones noncovalentes cum multis speciebus compositorum inclusas parvas moleculas organicas, peptides et proteins.Potest etiam augere eorum solutionem ac stabilitatem in aqua.Prima applicatio sulfobutyletheris bcyclodextri erat in injecta praeparatione;adhiberi potest etiam in formis solidis et liquidis dosis oralis, et in ophthalmicis, inhalationibus et in formulationibus intranasalibus.Betadex Sulfobutyl Ether Sodium agere potest ut agente osmotico et/vel solubilizer pro partus dimissionis sobrietatis et proprietates antimicrobiales conservativas cum sufficienti concentratione praesentes habet.Copia Betadex Sulfobutyl Ether Sodium quae adhiberi potest, pendet a proposito inclusionis in formula, via administrationis, et facultate cyclodextrini complexionis cum medicamento liberato.

182410-00-0 - Salus:

Betadex Sulfobutyl Ether Sodium ab b-cyclodextrin oritur, quod nephrotoxicum cum parenteraliter administratum est.Studia tamen docuerunt sulfobutyletheram bcyclodextrin bene tolerari in dosibus altis, cum per injectiones bolus intravenous, ore et inspiratione administrata.Usque ad 9 g/dies potest per IV infusionem in formula voriconazoli licentiati administrari.Salus sequentes altae doses sulfobutyletherarum β-cyclodextrinum intravenae administrationis in hominibus continue investigantur.Betadex Sulfobutyl Ether Sodium in vitro et in genotoxicitate vivo et aestimationes pharmacologicas amplae pugnae subiecta est.Nullae mutationes genotoxicae vel mutagenicae observatae sunt cum administratione Ether Sodium Betadex Sulfobutyl.Betadex Sulfobutyl Ether Sodium biocompatibilis est et nullam actionem pharmacologicam exhibet.Celeriter unmetabolum est cum intravenously administratum tollitur.

182410-00-0 - Regulatory Status:

Betadex Sulfobutyl Ether Sodium in IV et IM injecta producta in USA, Europa et Iaponia nunc approbata et vendita comprehenditur.In Ingredientia Inactive FDA Database pro IM et IV usu comprehenditur.Usus eius aliis itineribus, etiam SC, ore, inhalatione, nasi et ophthalmico, aestimatur in studiis clinicis.

182410-00-0 - Praeparatio:

Utens β-cyclodextrinum et 1,4-sulfobutyrolactonum ut materias rudis, congruam quantitatem organici solvendi in alcalinum solutionem aqueam introducendo, augetur solubilitas 1,4-sulfobutyrolactonum, et synthesis cedit sulfobutyli aetheris β-cyclodextrin. emendatur;solutio producti consecuta subiecta dialysi ultrasonica, decoloratio carbonis reducitur, siccitate congelatur et aliae operationes ut sulfobutyl-β-cyclodextrin pulveris products obtineant.

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