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

Betadex Sulfobutyl Ether Sodium
C42H70-nO35 · (C4H8SO3Na) n 2163 lokacin da n = 6.5
Beta cyclodextrin sulfobutyl ethers, sodium salts;
Beta cyclodextrin sulfobutyl ether sodium [182410-00-0].
BAYANI
Betadex Sulfobutyl Ether Sodium an shirya shi ta hanyar alkylation na betadex ta amfani da 1,4-butane sultone a ƙarƙashin yanayin asali.
Matsakaicin matsayi na maye a cikin betadex shine NLT 6.2 da NMT 6.9.
Ya ƙunshi NLT 95.0% da NMT 105.0% na C42H70−nO35 · (C4H8SO3Na) n (n = 6.2-6.9), ƙididdiga akan tushen anhydrous.
GANO
• A. RASHIN NUTSUWA <197K>
• B. Lokacin riƙewa na babban kololuwar samfurin samfurin ya dace da na daidaitaccen bayani, kamar yadda aka samu a cikin Assay.
• C. Ya cika ka'idojin gwaji don Matsakaicin Digiri na Sauyawa.
D. GWAJIN GANE-JAMA'A, Sodium 〈191〉
ASSAY
• TSARI
Lokacin wayar hannu: 0.1M potassium nitrate a cikin cakuda acetonitrile da ruwa (1: 4)
Daidaitaccen bayani: 10 mg/mL na USP Betadex Sulfobutyl Ether Sodium RS a cikin Waya lokaci
Maganin samfurin: 10 mg/mL na Betadex Sulfobutyl Ether Sodium a cikin Wayar hannu lokaci
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Yanayin: LC
Mai ganowa: Fihirisar Refractive
Zazzabi mai ganowa: 35 ± 2°
Tushen: 7.8-mm × 30-cm shafi na nazari;Farashin L37.[NOTE-Rinse shafi tare da maganin acetonitrile da ruwa (1:9) a ƙarshen jerin gudu.]
Yawan gudu: 1.0 ml/min
Girman allura: 20µL
Dacewar tsarin .
Misali: Daidaitaccen bayani
Abubuwan da suka dace
Matsakaicin madaidaicin dangi: NMT 2.0%
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi lissafin adadin betadex sulfobutyl ether sodium [C42H70-nO35 · (C4H8SO3Na) n] a cikin ɓangaren Betadex Sulfobutyl Ether Sodium da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × 100
rU = kololuwar amsa ga betadex sulfobutyl ether
sodium daga Samfurin bayani
rS = kololuwar amsa don betadex sulfobutyl ether
sodium daga Standard bayani
CS = maida hankali na USP Betadex Sulfobutyl Ether
Sodium RS a cikin Standard bayani (mg/ml)
CU = maida hankali na Betadex Sulfobutyl Ether Sodium a cikin Samfurin bayani (mg/mL)
Sharuɗɗan karɓa: 95.0% ~ 105.0% akan tushen anhydrous
RASHIN ZUCIYA
• KARFE MAI KYAU, Hanyar II <231>: NMT 5 ppm
IYAKA NA BETA CYCLODEXTRIN (BETADEX)
Magani A: 25 mM sodium hydroxide
Magani B: 250 mM sodium hydroxide da 1 M potassium nitrate
Matakin Wayar hannu: Duba Table 1.
Tebur 1

Daidaitaccen bayani: 2 μg/ml na USP Beta Cyclodextrin RS
Maganin samfurin: 2 MG / ml na Betadex Sulfobutyl Ether Sodium
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsari da Ion Chromatography <1065>.)
Yanayin: IC
Mai ganowa: pulsed amperometry (kwayoyin amperometric tare da lantarki mai aiki na zinariya da na'urar magana ta azurfa)
Rukunin
Tsaro: 4.0-mm × 5-cm canjin anion;Farashin L61
Analytical: 4.0-mm × 25-cm canjin anion;
Farashin L61
Yanayin zafin jiki: 50 ± 2°
Yawan gudu: 1.0 ml/min
Girman allura: 20µL
Waveform don mai gano amperometric pulsed: Duba Tebu 2.
Table 2

Dacewar tsarin
Misali: Daidaitaccen bayani
Abubuwan da suka dace
Matsakaicin madaidaicin dangi: NMT 5.0%
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi lissafin adadin beta cyclodextrin (betadex) a cikin ɓangaren Betadex Sulfobutyl Ether Sodium da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × F × 100
rU = kololuwar amsa don beta cyclodextrin daga Maganin Samfurin
rS = kololuwar amsa don beta cyclodextrin daga daidaitaccen bayani
CS = maida hankali na USP Beta Cyclodextrin RS a cikin daidaitaccen bayani (µg/ml)
CU = maida hankali na Betadex Sulfobutyl Ether Sodium a cikin Samfurin bayani (mg/mL)
F = yanayin jujjuyawa (10-3 mg/µg)
Sharuɗɗan karɓa: NMT 0.1%
• IYAKA NA 1,4-BUTANE SULTONE
Maganin daidaitaccen ciki: 0.25 μg/ml na diethyl sulfone
Daidaitaccen bayani na samfurin A: 0.5 µg/mL na 1,4-butane sultone
Daidaitaccen bayani na hannun jari B: 1.0 μg/ml na 1,4-butane sultone
Daidaitaccen bayani na hannun jari C: 2.0 μg/mL na 1,4-butane sultone
Maganin samfurin samfurin: 250 mg/mL na Betadex Sulfobutyl Ether Sodium a cikin daidaitaccen bayani na ciki
Maganin Blank, da Samfuran mafita A, B, C, da D:
Bi Tebu 3 don sanya adadin daidaitaccen bayani na ciki, kowane daidaitaccen bayani na hannun jari, Samfurin bayani na hannun jari, ruwa, ko methylene chloride a cikin kowane bututun gwajin gilashi tare da tasha.[NOTE-A dunƙule-capped, 10-mL gwajin tube ya dace.] Mix a kan vortex mahautsini kowane gwajin tube na 30 s, da kuma ba da damar ta tsaya na akalla 5 min ko har sai cikakken rabuwa da lokaci.Cire tsarin kwayoyin halitta a cikin vial GC da hatimi.[NOTE-Tare da babban kulawa ɗauki mafi ƙarancin yuwuwar adadin lokaci mai ruwa.] Ƙara adadin 1,4-butane sultone a cikin Samfurin mafita A, B, C, da D sune 0.5, 1.0, 2.0, da 0 μg, bi da bi.
Table 3

[NOTE-Shirya nan da nan kafin amfani.]
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Yanayin: GC
Mai ganowa: ionization na harshen wuta
Tushen: 0.32-mm × 25-m fused-silica capillary shafi;0.5-µm Layer na lokaci G46
Zazzabi
Mai ganowa: 270°
tashar allura: 200°
Rukunin: Duba tsarin zafin jiki a cikin Tebu 4
Table 4
Zazzabi Na Farko (°) Matsayin Zazzabi (°/min) Zazzabi na Ƙarshe (°) Riƙe Lokacin a Zazzabi na Ƙarshe (min)
100 10 200 -
200 35 270 5
Gas mai ɗaukar nauyi: Helium, yawanci a matsa lamba 12 psi
Girman allura: 1.0 µL
Nau'in allura: allura mara tsaga na 0.5 min, sannan a raba a 50 ml/min.[NOTE-Ana ba da shawarar yin amfani da layin allura da ya dace mara tsaga.]
Dacewar tsarin
Misali: Samfurin Magani B
[NOTE-Lokacin riƙe dangi don diethyl sulfone da 1,4-butane sultone sune 0.7 da 1.0, bi da bi.]
Abubuwan da suka dace
Matsakaicin madaidaicin dangi: NMT 10.0%
Bincike
Misalai: Maganin Blank, Samfuran mafita A, B, C, da D
Daidaita rabon kololuwar martani na 1,4-butane sultone zuwa diethyl sulfone a cikin Samfurin bayani A, B, C, ko D ta hanyar rage rabon martanin kololuwar sulton 1,4-butane zuwa ethyl sulfone a cikin Maganin Blank .Yi ƙirƙira daidaitaccen rabo na kololuwar martani na 1,4-butane sultone zuwa kololuwar martani na diethyl sulfone a cikin Sample bayani A, B, C ko D, tare da ƙarin adadin, a cikin µg, na 1,4-butane sultone.Extrapolate layin da ke haɗa maki akan jadawali har sai ya dace da axis na yawa.Nisa tsakanin wannan batu da mahadar gatari yana wakiltar adadin 1,4-butane sultone, A, a cikin µg, a cikin ɓangaren 4-mL na samfurin samfurin samfurin.Yi lissafin abun ciki na 1,4-butane sultone a cikin ɓangaren Betadex Sulfobutyl Ether Sodium da aka ɗauka:
Sakamako = A/(VExt × CU × F)
A = ƙaddara a sama
VExt = ƙarar samfurin samfurin samfurin da aka yi amfani da shi a matakin hakar, 4.0 ml
CU = maida hankali na Betadex Sulfobutyl Ether Sodium a cikin Samfurin samfurin samfurin (mg/mL)
F = yanayin jujjuyawa (10-3 g/mg)
Sharuɗɗan karɓa: hydroxybutane-1-sulfonic acid, ko NMT 0.5 ppm
Iyakar SODIUM chloride, 4-HYDROXYBUTANE-1-SULFONIC ACID, DA BIS(4-SULFOBUTYL) ETHER DISODIUM.
Magani A: 5 mM sodium hydroxide, degas a cikin rufaffiyar jirgin ruwa na 15 min
Magani B: 25 mM sodium hydroxide, degas a cikin rufaffiyar jirgin ruwa na 15 min
Matakin Wayar hannu: Duba Table 5
Table 5

Maganin wanke ginshiƙi A: 50 mM sodium citrate
Maganin wanke ginshiƙi B: 150 mM sodium hydroxide
Daidaitaccen bayani: Shirya bayani tare da sanannun ƙididdiga na 8 µg/mL na USP Sodium Chloride RS, 4µg/mL na 4-hydroxybutane-1-sulfonic acid, da 4 μg/mL na bis (4-sulfobutyl) ether disodium.
Maganin samfurin: 4 mg/mL na Betadex Sulfobutyl Ether Sodium
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsari da Ion Chromatography <1065>.)
Yanayin: IC
Mai ganowa: Haɓakawa
Matsakaicin iyaka: 30µS
A halin yanzu: 100mA
Rukunin: [NOTE-A ƙarshen kowane gudu, tsaftace ginshiƙi ta amfani da Maganin Wankin Rukunin A a cikin ƙimar 1 mL / min na 35 min sannan amfani da Maganin Wankin Rukunin B a daidai wannan ƙimar na 35 min.]
Tsaro: 4.0-mm × 5.0-cm canjin anion;Farashin L61
Analytical: 4.0-mm × 25-cm canjin anion;Farashin L61
Yanayin zafin jiki: 30°
Suppressor: Micromembrane anion autosuppressor1 ko tsarin da ya dace na kashe sinadarai
Mai hanawa: Tashin hankali
Yawan gudu: 1.0 ml/min
Girman allura: 20µL
Dacewar tsarin
Misali: Daidaitaccen bayani
[NOTE-Lokacin riƙewa na dangi an ba da shi don bayani kawai.Lokacin riƙe dangi na 4-hydroxybutane-1-sulfonate ion, chloride ion, da bis (sulfobutyl) ether ion sune 1.0, 1.4, da 8.6, bi da bi.]
Abubuwan da suka dace
Resolution: NLT 2.0
Matsakaicin madaidaicin dangi: NMT 10.0%
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi lissafin adadin sodium chloride, 4-hydroxybutane-1-sulfonic acid, ko bis (sulfobutyl) ether disodium a cikin ɓangaren Betadex Sulfobutyl Ether Sodium da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × F × 100
rU = amsa mafi girma don sodium chloride, 4-hydroxybutane-1-sulfonic acid, ko bis (sulfobutyl) ether disodium daga samfurin samfurin
rS = kololuwar amsa don sodium chloride, 4-hydroxybutane-1-sulfonic acid, ko bis (sulfobutyl) ether disodium daga daidaitaccen bayani.
CS = maida hankali na sodium chloride, 4-hydroxybutane-1-sulfonic acid, ko bis (sulfobutyl) ether disodium a cikin daidaitaccen bayani (µg/mL)
CU = maida hankali na Betadex Sulfobutyl Ether Sodium a cikin Samfurin bayani (mg/mL)
F = yanayin jujjuyawa (10-3 0 100 0 mg/µg)
Sharuɗɗan karɓa
Sodium chloride: NMT 0.2%
4-Hydroxybutane-1-sulfonic acid: NMT 0.09%
Bis (sulfobutyl) ether disodium: NMT 0.05%
MAKAMMAN JARRABAWA
GWAJIN BACTERIAL ENDOTOXINS <85>: Matsayin kwayoyin endotoxins shine abin da ake buƙata a ƙarƙashin nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau’in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau’in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau’in nau’in nau’in nau’in nau’in nau’in) wanda ake amfani da shi ana iya saduwa da shi.Inda lakabin ya bayyana cewa betadex sulfoboury dole a ci gaba da aiki yayin shirye-shiryen ƙwayoyin cuta da ake amfani da shi a cikin betadex sulfobobobobobobobobobobobobobobobobobobobobobobobobobobobobobobobob ether za a iya saduwa.
• GWAJIN KIMIYYA NA MIKIRIYA <61> da GWAJI GA YANAR GWAMNATIN KANKANIN MIKIROORGANISMS <62>: Jimillar ƙididdige ƙananan ƙwayoyin cuta na aerobic bai wuce 100 cfu/g ba, kuma jimlar haɗe-haɗe da ƙidaya yisti bai wuce 50 cfu/g ba.Ya cika ka'idodin gwajin don rashin Escherichia coli.
• BAYANIN MAGANI
Maganin samfurin: 30% (w/v) bayani
Nazari: Bincika Maganin Samfurin ta amfani da akwatin haske a gaban farare da baƙar fata, da yin rikodin kasancewar duk wani hazo, haske, filaye, ɗigo, ko wani abu na waje.
Sharuɗɗan karɓa: Mafita a bayyane take, kuma a zahiri ba ta da barbashi na al'amuran waje.
• Matsakaicin digiri na CANJIN
Gudun electrolyte: 30 mM benzoic acid kuma an daidaita shi zuwa pH wanda ya dace da kayan aikin da aka yi amfani da shi ta hanyar ƙari na 100 mM tris (hydroxymethyl) aminomethane buffer.
[NOTE-Saboda bambancin tsakanin capillaries, ba a kayyade pH guda ɗaya da ake amfani da su a duniya ba.
Madadin haka, mafi kyawun pH da ke hade da kowane capillary ya kamata a ƙayyade bisa ga littafin kayan aiki.]
Daidaitaccen bayani: 10 mg/mL na USP Betadex Sulfobutyl Ether Sodium RS
Maganin samfurin: 10 mg/mL na Betadex Sulfobutyl Ether Sodium
Hanyar kurkurawar capillary: Yi amfani da filaye daban-daban na electrolyte don kurkura capillary da nazarin samfurin.Yi pre-bincike rinses a kowace rana kafin kowane bincike: kurkura capillary tare da 0.1 N sodium hydroxide na 30 min, da ruwa ga NLT 2 h, kuma tare da Run electrolyte for NLT 1 h.Yi wanke-wanke kafin allura kafin kowace allura kamar haka.Kurkura capillary tare da 0.1 N sodium hydroxide don NLT 1 min, kuma tare da Run electrolyte na NLT 3 min.Idan ana amfani da sabon capillary, baya ga kurkura na yau da kullun da aka kwatanta a sama, sabon capillary yana buƙatar kurkura kafin amfani da shi na farko.Kurkura sabon capillary tare da 1 M sodium hydroxide na awa 1, sannan a wanke ruwa na awanni 2.
Electrophoretic tsarin
(Duba Capillary Electrophoresis <1053>.)
Yanayin: Babban aikin CE
Mai ganowa: Inverse UV 200nm, tare da bandwidth na 20nm.[NOTE-Za a iya amfani da tsayin tsayin tsayin 205nm tare da bandwidth na 10nm azaman madadin.]
Tushen: Kololuwar Sodium I–X (% Wurin Kololuwa) 50-µm × 50-cm Fused silica ginshiƙi
Yanayin zafin jiki: 25°
Wutar lantarki mai aiki: 0.00 zuwa + 30.00 kV madaidaiciyar ramp sama da mintuna 10, sannan a 30 kV don ƙarin 20 min.
Girman allura: Daidaitaccen juzu'i a 0.5 psi na s 10
Dacewar tsarin
Misali: Daidaitaccen bayani
[NOTE-Duba Table 6 don kimanin lokutan ƙaura na dangi don betadex sulfobutyl ether sodium kololuwar I-X (betadex sulfobutyl ether sodium kololuwa I, II, III, ..., X, ya ƙunshi kwayoyin beta cyclodextrin tare da 1, 2, 3, ..., 10 sulfobutyl madadin(s), bi da bi).Lokutan ƙaura na dangi don dalilai ne na bayanai kawai don taimakawa cikin gano kololuwar.]
Table 6

Abubuwan da suka dace
Resolution: NLT 0.9, tsakanin betadex sulfobuty ether sodium peak IX da betadex sulfobutyl ether sodium peak X
Bincike
Samfurori: Gudu electrolyte, ruwa, Daidaitaccen bayani, da Samfurin bayani
Aiwatar da daidaitaccen bayani da samfurin samfurin ta hanyar yin amfani da matsa lamba daban-daban na 0.5 psi, daidai da 34 mbar, don 10 s, sannan allurar Run electrolyte a 0.5 psi don 2 s.[NOTE-Matsi allura ya kamata a yi da wani vial na ruwa ko Run electrolyte a kan kanti karshen capillary.]
Yi rikodin electropherograms, kuma auna mafi girman martani ga betadex sulfobutyl ether sodium kololuwa (I zuwa X).Ƙididdigar yankin kololuwar da aka gyara, AI, ga kowane kololuwa a cikin eletropherogram:
Wuri Mafi Girma A = Wurin Kololuwa x Ingantacciyar Tsawon Jiki (cm) / Lokacin Hijira
Daidaita wuraren kololuwar da aka gyara ta hanyar gabatar da kowanne a matsayin kaso na jimlar yankin ambulan da aka gyara:
Wurin da aka kayyade, NA: A / n∑i=1 Ai x 100
n = mafi girman matakin canji
Ƙayyade matsakaicin matsayi na maye:
Matsakaicin Matsakaicin Matsakaici = n∑i=1 (Mataki na Sauyawa don Peak x NA) / 100
Sharuɗɗan karɓa: 6.2 ~ 6.9 don matsakaicin matsayi na maye gurbin
Ga kowane betadex sulfobutyl ether sodium kololuwa I-X, duba iyaka iyaka (% yanki mafi girma) a cikin Tebura 7.
Table 7

• PH <791>: 4.0-6.8, a cikin 30% (w/v) bayani a cikin ruwa maras carbon dioxide
• SANARWA RUWA, Hanyar I <921>: NMT 10.0%
KARIN BUKATA
• KYAUTA DA ARJIYA: Ajiye a cikin kwantena da aka rufe sosai, kuma a adana a zafin jiki.Kare daga danshi.
LABELING: Sanya alama don nuna amfani da shi wajen kera fom ɗin allura.
• MATSAYIN MAGANAR USP <11>
USP Beta Cyclodextrin RS
USP Betadex Sulfobutyl Ether Sodium RS
USP Endotoxin RS
USP Sodium Chloride RS■1S (NF30)