SBE-β-CD CAS 182410-00-0 Betadex Sulfobutyl Ether Sodium Assay 95.0~105.0%
Ko Ruifu Chemical te kaihanga matua o Betadex Sulfobutyl Ether Sodium (SBE-β-CD; Captisol) (CAS: 182410-00-0) me te kounga teitei.Ka taea e Ruifu te tuku i te ao, te utu whakataetae, te ratonga pai, te iti me te rahinga e waatea ana.Hokona Betadex Sulfobutyl Ether Sodium,Please contact: alvin@ruifuchem.com
| Ingoa matū | Betadex Sulfobutyl Ether Konutai |
| Nga kupu taurite | SBE-β-CD;SBE-beta-CD;Captisol;Konutai Sulfobutylether β-Cyclodextrin;Konutai Sulphobutylether-beta-Cyclodextrin;Sulfobutylether beta-Cyclodextrin;Beta-Cyclodextrin Sulfobutyl Ethers Sodium Salts;β-Cyclodextrin Sulfobutyl Ethers Sodium Salts |
| Tūnga Taonga | I roto i te Stock, Production Arumoni |
| Tau CAS | 182410-00-0 |
| Tātai rāpoi | C42H70O35•xNa•x(C4H9O3S) |
| Taumaha rāpoi | (1134.99).x(22.99).x(137.17) g/mol |
| Iwi Whakarewa | 202.0~204.0 ℃(tikura) |
| Wairewa | Wairewa ki te wai.Karekau ki te Acetone, Methanol, Chloroform |
| Waehere HS | 3505100000 |
| COA & MSDS | Kei te waatea |
| Tauira | Kei te waatea |
| Taketake | Shanghai, Haina |
| Waitohu | Ruifu Chemical |
| Nga taonga | Nga Paerewa Tirotiro | Hua |
| Te ahua | Ma ki te Paura Amorphous White-White | Whakaritea |
| Tautuhinga IR | He rite nga roopu whakauru ki te USP Betadex Sulfobutyl Ether Sodium RS | Whakaritea |
| Tautuhinga HPLC | Ko te wa pupuri o te tihi nui o te otinga tauira e rite ana ki te otinga paerewa | Whakaritea |
| Waewaenga Waeine o te Whakakapi | Whakaritea | Whakaritea |
| Tautuhinga Konutai | Tautuhia he pai te whakamatautau mo te konutai | Whakaritea |
| Te whakamatautau | 95.0%~105.0% | 99.49% |
| Beta Cyclodextrin | ≤0.10% | Kaore i kitea |
| 1,4-Butane Sultone | ≤0.5ppm | 0.19ppm |
| konutai pūhaumāota | ≤0.20% | 0.003% |
| 4-Hydroxybutane-1-Sulfonic Acid | ≤0.09% | Kaore i kitea |
| Bis(4-Sulfobtyl) Etera Disodium | ≤0.05% | Kaore i kitea |
| Endotoxins huakita | ≤20EU/g | <5EU/g |
| Te Tatau Moroiti Aerobic Tapeke | ≤100cfu/g | <10cfu/g |
| Ka Tatauhia te Tapeke Whakakotahi i nga Moutere me te rewena | ≤50cfu/g | <10cfu/g |
| Escherichia Coli | Te korenga | Kaore i kitea |
| Maramatanga o te Otinga | 30%(w/v) te otinga he maamaa, he koretake mai i nga matūriki o nga mea ke. | Whakaritea |
| Waewaenga Waeine o te Whakakapi | 6.2~6.9 | 6.5 |
| Te tihi I | 0.0~0.3 | 0 |
| Te tihi II | 0.0~0.9 | 0.62 |
| Te tihi III | 0.5~5.0 | 1.41 |
| Te tihi IV | 2.0~10.0 | 4.46 |
| Te tihi V | 10.0~20.0 | 11.72 |
| Te tihi VI | 15.0~25.0 | 20.75 |
| Te tihi VII | 20.0~30.0 | 29.04 |
| Te tihi VIII | 10.0~25.0 | 21.59 |
| PeakI X | 2.0~12.0 | 7.83 |
| Te tihi X | 0.0~4.0 | 2.57 |
| pH | 4.0~6.8 | 4.8 |
| Ihirangi wai | ≤10.0% | 4.9% |
| Spectrum Infrared | He rite ki te Hanganga | Ka tutuki |
| Whakamutunga | Ko tenei hua ma te tirotiro ka rite ki te paerewa USP35 | |
Mōkī:Pounamu, Peeke konumohe konumohe, 25kg / Cardboard Drum, kia rite ranei ki te hiahia a te kaihoko.
Tikanga Rokiroki:Tiakina i roto i nga ipu kua kati pai, ka penapena ki roto i te whare putunga hauhautanga, maroke (2~8 ℃) me te hau pai kia matara atu i nga matū hotokore.Tiaki i te marama me te makuku.
Tukunga:Tukuna ki te ao ma te rangi, ma te FedEx / DHL Express.Whakaratohia te tuku tere me te pono.
Betadex Sulfobutyl Ether Konutai
C42H70−nO35 · (C4H8SO3Na)n 2163 inaa n = 6.5
Beta cyclodextrin sulfobutyl ethers, tote konutai;
Beta cyclodextrin sulfobutyl ether sodium [182410-00-0].
WHAKAMAHI
Ko te Betadex Sulfobutyl Ether Sodium he mea rite ma te alkylation o te betadex ma te whakamahi i te sultone 1,4-butane i raro i nga tikanga taketake.
Ko te tohu toharite o te whakakapi i te betadex ko te NLT 6.2 me te NMT 6.9.
Kei roto ko te NLT 95.0% me te NMT 105.0% o C42H70−nO35 · (C4H8SO3Na)n (n = 6.2–6.9), kua tatauhia i runga i te waikore.
WHAKATAUTANGA
• A. KAUPAPA INFRARED <197K>
• B. Ko te wa pupuri o te tihi nui o te otinga Tauira e rite ana ki tera o te otinga paerewa, i riro mai i te Assay.
• C. Ka tutuki ia i nga whakaritenga o te whakamatautau mo te Waeine Waehere Whakakapi.
• D. WHAKATAUTANGA WHAKATAUTANGA-WAHAHUI, Konutai 〈191〉
WHAKAMAHI
• TE WHAKAMAHI
Wāhanga pūkoro: 0.1 M pāhare pākawa pākawa i roto i te ranunga o te acetonitrile me te wai (1:4)
Te otinga paerewa: 10 mg / mL o USP Betadex Sulfobutyl Ether Sodium RS i roto i te waahanga Waea
Tauira otinga: 10 mg/mL o Betadex Sulfobutyl Ether Sodium i roto i te wahanga Waea Pukoro
Pūnaha Chromatographic
(Tirohia te Chromatography <621>, Whakaritenga Pūnaha.)
Aratau: LC
Kaitirotiro: Taupū Refactive
Te paemahana kaitirotiro: 35 ± 2°
Tīwae: 7.8-mm × 30-cm tīwae tātari;whakakai L37.[FAKATOKANGA-Ka horoia te pou ki te otinga o te acetonitrile me te wai (1:9) i te otinga o te raupapa oma.]
Rere rere: 1.0 mL/min
Rahi werohanga: 20 µL
Te pai o te punaha.
Tauira: otinga Paerewa
Nga whakaritenga e tika ana
Inenga Paerewa Paanga: NMT 2.0%
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te ōrau o te konutai betadex sulfobutyl ether [C42H70−nO35 · (C4H8SO3Na)n] i te wahanga o te Betadex Sulfobutyl Ether Sodium i tangohia:
Hua = (rU/rS) × (CS/CU) × 100
rU = te whakautu teitei mo te betadex sulfobutyl ether
konutai mai i te Tauira otinga
rS = whakautu teitei mo te betadex sulfobutyl ether
konutai mai i te otinga Paerewa
CS = te kukū o te USP Betadex Sulfobutyl Ether
Konutai RS i te otinga Paerewa (mg/mL)
CU = te kukū o te Betadex Sulfobutyl Ether Sodium i roto i te Tauira otinga (mg/mL)
Paearu whakaae: 95.0% ~ 105.0% i runga i te kaupapa anhydrous
NGA POKE
• NGA METAL TAHA, Tikanga II <231>: NMT 5 ppm
• TE TEITI O BETA CYCLODEXTRIN (BETADEX)
Rongoā A: 25 mM konutai waihā
Rongoā B: 250 mM konutai waihā me te 1 M pāhare pākawa pākawa
Wāhanga pūkoro: Tirohia te Ripanga 1.
Ripanga 1
| Wā (min) | Otinga A (%) | Otinga B (%) |
| 0 | 100 | 0 |
| 4 | 100 | 0 |
| 5 | 0 | 100 |
| 10 | 0 | 100 |
| 11 | 100 | 0 |
| 20 | 100 | 0 |
Te otinga paerewa: 2 µg/mL o USP Beta Cyclodextrin RS
Tauira otinga: 2 mg/mL o Betadex Sulfobutyl Ether Sodium
Pūnaha Chromatographic
(Tirohia te Chromatography <621>, Pūnaha Whakaritea me te Ion Chromatography <1065>.)
Aratau: IC
Kaitirotiro: Amperometry kua whakapouri (te pūtau amperometric me te hiko mahi koura me te hiko tohutoro hiriwa)
Tīwae
Kaitiaki: 4.0-mm × 5-cm te whakawhiti anion;whakakai L61
Tātari: 4.0-mm × 25-cm te whakawhiti anion;
whakakai L61
Te mahana o te pou: 50 ± 2°
Rere rere: 1.0 mL/min
Rahi werohanga: 20 µL
Hangangaru mo te puhoi amperometric puhoi: Tirohia te Ripanga 2.
Ripanga 2
| Wā (s) | Ngaohiko (V) |
| 0.00 | 0.10 |
| 0.30 | Tīmatahia te whakauru |
| 0.50 | 0.10 |
| 0.50 | Kati te whakauru |
| 0.51 | 0.60 |
| 0.60 | -0.60 |
| 0.65 | -0.60 |
Te pai o te punaha
Tauira: otinga Paerewa
Nga whakaritenga e tika ana
Inenga paerewa patata: NMT 5.0%
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te ōrau o te beta cyclodextrin (betadex) i te wahanga o te Betadex Sulfobutyl Ether Sodium i tangohia:
Hua = (rU/rS) × (CS/CU) × F × 100
rU = te whakautu teitei mo te beta cyclodextrin mai i te otinga Tauira
rS = te whakautu teitei mo te beta cyclodextrin mai i te otinga Paerewa
CS = te kukū o te USP Beta Cyclodextrin RS i te otinga Paerewa (µg/mL)
CU = te kukū o te Betadex Sulfobutyl Ether Sodium i roto i te Tauira otinga (mg/mL)
F = tauwehe tahuri (10-3 mg/µg)
Paearu whakaae: NMT 0.1%
• TE TEITI O 1,4-BUTANE SULTONE
Wairewa paerewa o roto: 0.25 µg/mL o diethyl sulfone
Wairewa rakau paerewa A: 0.5 µg/mL o te 1,4-butane sultone
Wairewa rakau paerewa B: 1.0 µg/mL o te 1,4-butane sultone
Wairewa rakau paerewa C: 2.0 µg/mL o te 1,4-butane sultone
Tauira otinga kararehe: 250 mg/mL o Betadex Sulfobutyl Ether Sodium i roto i te otinga paerewa o roto
Wairewa patea, me nga tauira otinga A, B, C, me D:
Whaia te Ripanga 3 ki te whakatakoto i nga rahinga o te wairewa paerewa o roto, ia otinga kararehe Paerewa, Tauira otinga kararehe, wai, me te methylene chloride ranei ki roto i ia ipuipu whakamatautau karaihe me te aukati.[FAKATOKANGA-He pai te ngongo whakamatautau 10-mL.] Whakaranuhia ki runga i te whakaranu vortex ia ngongo whakamatautau mo te 30 hēkona, ka tu mo te 5 meneti neke atu ranei kia oti ra ano te wehenga o te wahanga.Unuhia te wahanga waro ki roto i te ipu GC me te hiri.[FAKATOKANGA-Me tino tupato kia iti rawa te waahanga wai.] Ko nga rahinga taapiri o te 1,4-butane sultone i roto i nga Tauira otinga A, B, C, me D he 0.5, 1.0, 2.0, me te 0 µg.
Ripanga 3
| Ingoa Tauira | Otinga 1 Tāpirihia (mL) | Otinga 2 Kua taapirihia (mL) | Methylene Chloride kua taapirihia (mL) |
| Te otinga parakore | Te otinga paerewa o roto, 4.0 | Wai, 1.0 | 1.0 |
| Tauira otinga A | Tauira otinga kararehe, 4.0 | Ko te otinga rakau paerewa A, 1.0 | 1.0 |
| Tauira otinga B | Tauira otinga kararehe, 4.0 | Te otinga rakau paerewa B, 1.0 | 1.0 |
| Tauira otinga C | Tauira otinga kararehe, 4.0 | Wairewa rakau paerewa C, 1.0 | 1.0 |
| Tauira otinga D | Tauira otinga kararehe, 4.0 | Wai, 1.0 | 1.0 |
[MATUA-Whakaritea i mua tonu i te whakamahi.]
Pūnaha Chromatographic
(Tirohia te Chromatography <621>, Whakaritenga Pūnaha.)
Aratau: GC
Kaipupuri: Te katote mura
Tīwae: 0.32-mm × 25-m te tīwae capillary-silica;0.5-µm paparanga o te wahanga G46
Te pāmahana
Kaipupuri: 270°
Tauranga werohanga: 200°
Tīwae: Tirohia te hotaka pāmahana i te Ripanga 4
Ripanga 4
Paemahana Tuatahi (°) Paemahana Ramp (°/min) Wehenga Whakamutunga (°) Wā Puritia i te Wehana Whakamutunga (min)
100 10 200 -
200 35 270 5
Te hau kawe: Helium, te tikanga i te 12 psi te pehanga uru
Rahi werohanga: 1.0 µL
Momo werohanga: Werohia kore wehe mo te 0.5 meneti, ka wehea ki te 50 mL/min.[FAKATOKANGA-E taunaki ana kia whakamahia he riipene werohanga kore-waahi.]
Te pai o te punaha
Tauira: Tauira otinga B
[FAKATOKANGA-Ko nga wa pupuri mo te diethyl sulfone me te 1,4-butane sultone he 0.7 me te 1.0.]
Nga whakaritenga e tika ana
Inenga Paerewa Paanga: NMT 10.0%
Tātaritanga
Tauira: Wairewa Patea, Tauira otinga A, B, C, me D
Whakatikahia te ōwehenga o nga whakautu teitei o te 1,4-butane sultone ki te diethyl sulfone i roto i te Tauira otinga A, B, C, D ranei ma te tango i te ōwehenga o nga whakautu tihi o te 1,4-butane sultone ki te ethyl sulfone i roto i te wairewa Patea .Whakatakotoria te ōwehenga whakatika o te whakautu teitei o te 1,4-butane sultone ki te whakautu teitei o te diethyl sulfone i roto i te Tauira otinga A, B, C, D ranei, me te rahinga taapiri, i te µg, o te 1,4-butane sultone.Whakanuia te raina e hono ana i nga tohu o te kauwhata kia tutuki ra ano ki te tuaka rahinga.Ko te tawhiti i waenga i tenei waahi me te mokowhititanga o nga toki e tohu ana i te rahinga o te 1,4-butane sultone, A, i roto i te µg, i roto i te wahanga 4-mL o te otinga kararehe Tauira.Tātaihia te ihirangi o te sultone 1,4-butane i te wahanga o te Betadex Sulfobutyl Ether Sodium i tangohia:
Hua = A/(VExt × CU × F)
A = kua whakatauhia i runga ake nei
VExt = rōrahi o te Tauira otinga kararehe i whakamahia i te taahiraa tangohanga, 4.0 mL
CU = te kukū o te Betadex Sulfobutyl Ether Sodium i roto i te otinga kararehe Tauira (mg/mL)
F = tauwehe tahuri (10-3 g/mg)
Paearu whakaae: hydroxybutane-1-sulfonic acid, NMT 0.5 ppm ranei
• TE TEITI O SODIUM CHLORIDE, 4-HYDROXYBUTANE-1-SULFONIC ACID, ME BIS(4-SULFOBUTYL) ETHER DISODIUM
Rongoā A: 5 mM konutai waihā, degas i roto i te ipu kati mo te 15 min
Rongoā B: 25 mM konutai waihā, degas i roto i te ipu kati mo te 15 min
Wāhanga pūkoro: Tirohia te Ripanga 5
Ripanga 5
| Wā (min) | Otinga A (%) | Otinga B(%) |
| 0 | 100 | 0 |
| 4 | 100 | 0 |
| 10 | 70 | 30 |
| 24 | 70 | 30 |
| 25 | 100 | 0 |
| 40 | 100 | 0 |
Wairewa horoi tīwae A: 50 mM konutai citrate
Te wairewa horoi o te tīwae B: 150 mM konutai waihā
Wairewa Paerewa: Whakaritea he otinga e mohio ana te 8 µg/mL o te USP Sodium Chloride RS, 4µg/mL o te waikawa 4-hydroxybutane-1-sulfonic, me te 4 µg/mL o te bis(4-sulfobutyl) ether disodium.
Tauira otinga: 4 mg/mL o Betadex Sulfobutyl Ether Sodium
Pūnaha Chromatographic
(Tirohia te Chromatography <621>, Pūnaha Whakaritea me te Ion Chromatography <1065>.)
Aratau: IC
Kaitirotiro: Kawenga
Awhe: 30 µS
Nāianei: 100 mA
Tīwae: [KORE-I te mutunga o ia oma, horoia te pou ma te whakamahi i te wairewa horoi o te Tiwae A i te reiti rere 1 mL/mene mo te 35 meneti ka whakamahi i te wairewa horoi o te Tiwae B i te reiti rere rite mo te 35 meneti.]
Kaitiaki: 4.0-mm × 5.0-cm te whakawhiti anion;whakakai L61
Tātari: 4.0-mm × 25-cm te whakawhiti anion;whakakai L61
Te pāmahana tīwae: 30°
Kaipupuri: Micromembrane anion autosuppressor1, he punaha whakakore matū pai ranei
Kaipupuri: Aunoa
Rere rere: 1.0 mL/min
Rahi werohanga: 20 µL
Te pai o te punaha
Tauira: otinga Paerewa
[FAKATOKANGA-Ko nga wa pupuri whanaunga ka tukuna mo nga korero anake.Ko nga wa pupuri mo te 4-hydroxybutane-1-sulfonate katote, katote chloride, me te bis(sulfobutyl) eter katote he 1.0, 1.4, me te 8.6.]
Nga whakaritenga e tika ana
Whakatau: NLT 2.0
Inenga Paerewa Paanga: NMT 10.0%
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te ōrau o te konutai pūhaumāota, 4-hydroxybutane-1-sulfonic acid, bis(sulfobutyl) ether disodium ranei i roto i te wahanga o te Betadex Sulfobutyl Ether Sodium i tangohia:
Hua = (rU/rS) × (CS/CU) × F × 100
rU = te whakautu teitei mo te konutai pūhaumāota, 4-hydroxybutane-1-sulfonic acid, bis(sulfobutyl) ether disodium mai i te Tauira otinga
rS = te whakautu teitei mo te konutai pūhaumāota, 4-hydroxybutane-1-sulfonic acid, bis(sulfobutyl) ether disodium mai i te otinga Paerewa
CS = te kukū o te konutai pūhaumāota, 4-hydroxybutane-1-sulfonic acid, bis(sulfobutyl) ether disodium ranei i roto i te otinga Paerewa (µg/mL)
CU = te kukū o te Betadex Sulfobutyl Ether Sodium i roto i te Tauira otinga (mg/mL)
F = tauwehe tahuri (10−3 0 100 0 mg/µg)
Paearu whakaae
konutai pūhaumāota: NMT 0.2%
4-Hydroxybutane-1-sulfonic acid: NMT 0.09%
Bis(sulfobutyl) ether disodium: NMT 0.05%
NGA WHAKAMATAUTANGA
WHAKAMAHI WHAKAMAHI I TE ENDOTOXINS BACTERIAL <85>: Ko te taumata o nga endotoxins huakita ka taea te whakatutuki i te whakaritenga i raro i te puka inenga e tika ana mo te monograph(s) e whakamahia ai te Betadex Sulfobutyl Ether Sodium.Mena e kii ana te tapanga ko te Betadex Sulfobutyl Ether Sodium me tukuna ki te tukatuka ano i te wa e whakarite ana i nga puka inenga werohia, ko te taumata o nga endotoxins huakita ko te whakaritenga i raro i te (nga) o te puka inenga e tika ana hei whakamahi i te Betadex Sulfobutyl Ether Sodium. ka taea te tutaki.
• NGA WHAKAMAHI WHAKATAUTANGA MICROBIAL <61> me nga WHAKATAUTANGA MO NGA MICROORGANISME WHAKATAHI <62>: Ko te tapeke o te moroiti aerobic e kore e neke ake i te 100 cfu/g, me te tapeke o nga kohanga me nga rewena kua whakauruhia kia kaua e neke ake i te 50 cfu/g.Ka tutuki nga whakaritenga o te whakamatautau mo te kore o Escherichia coli.
• TE MAMARANGA O TE WHAKAMAHI
Tauira otinga: 30% (w/v) otinga
Tātaritanga: Tirohia te Tauira otinga ma te whakamahi i te pouaka marama ki te papamuri ma me te pango, ka tuhi i te ahua o te kohu, te korakora, te muka, te kowhatu, me etahi atu mea ke.
Paearu whakaae: He maamaa te otinga, he koretake mai i nga matūriki o nga mea ke.
• TE WAETANGA WATAHI O TE KAUPAPA
Rere electrolyte: 30 mM waikawa benzoic ka whakatika ki te pH e pai ana mo te taputapu e whakamahia ana ma te taapiri i te 100 mM tris(hydroxymethyl) aminomethane buffer.
[FAKATOKANGA-Na te rereketanga i waenga i nga capillaries, karekau tetahi pH electrolyte e tika ana mo te ao katoa i tohua.
Engari, ko te pH tino pai e pa ana ki ia kapila takitahi me whakatau i runga i te pukapuka taputapu.]
Te otinga paerewa: 10 mg/mL o USP Betadex Sulfobutyl Ether Sodium RS
Tauira otinga: 10 mg/mL o Betadex Sulfobutyl Ether Sodium
Te tikanga horoi kapi: Whakamahia nga ipu hiko motuhake mo te horoi kapi me te tātari tauira.Me horoi i mua i te tātaritanga i ia ra i mua i ia tātaritanga: horoia te kapi ki te 0.1 N konutai waikawa mo te 30 meneti, ki te wai mo te NLT 2 haora, me te Run electrolyte mo te NLT 1 haora.Me horoi i mua i te werohanga i mua i ia werohanga penei.Horoia te kapi ki te 0.1 N konutai waikawa mo te NLT 1 meneti, me te Run electrolyte mo te NLT 3 min.Mena kei te whakamahia he kapi hou, i tua atu i nga horoinga auau e whakaahuatia ana i runga ake nei, me horoi te kapi hou i mua i te whakamahinga tuatahi.Horoihia te kapi hou ki te 1 M konutai waikawa mo te 1 haora, whai muri i te horoi wai 2-haora.
Pūnaha hiko
(Tirohia te Capillary Electrophoresis <1053>.)
Aratau: CE teitei-mahi
Kaitirotiro: UV Kōaro 200 nm, me te hōkaiipurangi o 20nm.[FAKATOKANGA-Ka taea te whakamahi i te roangaru rapu o te 205 nm me te bandwidth 10 nm.]
Tīwae: Pūkeka konutai I–X (% Horahanga Peak) 50-µm × 50-cm te tiihi silica whakakotahi
Te mahana o te pou: 25°
Ngaohiko kua whakamahia: 0.00 ki te +30.00 kV te reanga raina mo te 10 meneti, ka 30 kV mo te 20 meneti atu
Rahi werohanga: He rite nga pukapuka ki te 0.5 psi mo te 10 hēkona
Te pai o te punaha
Tauira: otinga Paerewa
[FAKATOKANGA-Tirohia te Ripanga 6 mo nga wa hekenga tata mo te betadex sulfobutyl ether konutai tihi I–X (betadex sulfobutyl ether konutai peaks I, II, III, ..., X, kei roto te ngota ngota cyclodextrin beta me te 1, 2, 3, ..., 10 sulfobutyl substituent(s), ia.Ko nga wa hekenga mo nga kaupapa korero anake hei awhina i te tohu tohu teitei.]
Ripanga 6
| Betadex Sulfobutyl Ether Sodium Peaks I–X | Wā Hekenga Whanaunga |
| I | 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 |
Nga whakaritenga e tika ana
Whakataunga: NLT 0.9, i waenganui i te peak konutai betadex sulfobuty ether IX me te tihi konutai betadex sulfobutyl ether X
Tātaritanga
Tauira: Whakahaerehia te electrolyte, te wai, te otinga Paerewa, me te otinga Tauira
Werohia te otinga Paerewa me te otinga Tauira ma te whakamahi i te pehanga rereke o te 0.5 psi, he rite ki te 34 mbar, mo te 10 s, ka whai i te werohanga o te Run electrolyte i te 0.5 psi mo te 2 s.[FAKATOKANGA-Me mahi nga werohanga pehanga ki te ipu wai, ki te Run electrolyte ranei i te pito putanga o te kapi.]
Tuhia nga electropherograms, me te ine i nga whakautu tihi mo nga tihi konutai betadex sulfobutyl ether (I ki X).Tātaihia te horahanga tihi kua whakatikahia, AI, mo ia tihi o te eletropherogram:
Te Horahanga Peak Whakatika A = Te Horahanga Peak x Te roa o te Capillary Whaihua (cm) / Wa Heke
Whakaritehia nga waahi tihi kua whakatikahia ma te whakaatu i ia waahanga hei paheketanga o te katoa o te waahi whakakapinga whakakapinga:
Horahanga Whakapaipai, NA: A / n∑i=1 Ai x 100
n = taumata teitei o te whakakapinga
Whakatauhia te tohu toharite o te whakakapinga:
Waeine Wawaenga o te Whakakapi = n∑i=1 (Taumata o te Whakakapi mo te Peak x NA) / 100
Paearu whakaae: 6.2~6.9 mo te tohu toharite o te whakakapi
Mo ia betadex sulfobutyl ether konutai tihi I–X, tirohia te awhe tepe (% te horahanga tihi) kei te Ripanga 7.
Ripanga 7
| Betadex Sulfobutyl Ether Sodium Peaks I–X | Awhe Tepe (% Horahanga Peak) |
| 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 | 20.0-30.0 |
| VIII | 10.0-25.0 |
| IX | 2.0-12.0 |
| X | 0-4.0 |
• PH <791>: 4.0-6.8, i roto i te wairewa 30% (w/v) i roto i te wai waro-kore-kore
• WHAKATAUTANGA WAI, Tikanga I <921>: NMT 10.0%
HE WHAKAMAHI ATU
• TE PAKITANGA ME TE WHAKAPUTANGA: Whakaorangia ki roto i nga ipu kua kati pai, ka penapena ki te pāmahana rūma.Tiaki i te makuku.
• TARANGA: Tapahia hei tohu i tona whakamahinga ki te hanga i nga puka inenga werohia.
• USP REFERENCE STANDARD <11>
USP Beta Cyclodextrin RS
USP Betadex Sulfobutyl Ether Konutai RS
USP Endotoxin RS
USP Sodium Chloride RS■1S (NF30)
Me pehea te hoko?Whakapā maiDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com
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Tauira?Ko te nuinga o nga hua e whakarato ana i nga tauira kore utu mo te aromatawai kounga, me utu nga utu kaipuke e nga kaihoko.
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Ko te Betadex Sulfobutyl Ether Sodium (SBE-β-CD; Captisol) (CAS: 182410-00-0) he momo hou o te cyclodextrin whakarereke matū me te hanganga i hangaia hei arotau i te whakarewatanga me te pumau o nga raau taero.
Ko te Betadex Sulfobutyl Ether Sodium he momo hou o te rongoa whakarite rongoa, no roto i te waikawa sulfonic o te cyclodextrin tino wairewa-wai-anoniki.Ka taea te whakakotahi pai ki nga ngota ngota tarukino hei hanga i nga matatini kore-covalent, e pai ake ai te pumau, te wairewa o te wai, me te haumaru o te tarukino, me te whakapai ake i te mahi koiora o te ngota ngota tarukino.He iti tona nephrotoxicity, a ka taea e ia te whakaiti i te hemolysis tarukino., Whakahaerehia te tere o te tuku tarukino.
Ka taea e te Betadex Sulfobutyl Ether Sodium te hanga i nga matatini noncovalent me te maha o nga momo puhui tae atu ki nga ngota ngota waro iti, peptides, me nga pūmua.Ka taea hoki te whakarei ake i to ratau whakarewatanga me te pumau i roto i te wai.Ko te tono tuatahi o te sulfobutylether bcyclodextrin i roto i nga whakaritenga werohanga;Ka taea hoki te whakamahi i roto i nga puka totika totoka me te wai, me te ophthalmic, inhalation, me nga hanganga intranasal.Ka taea e te Betadex Sulfobutyl Ether Sodium te mahi hei kaihoko osmotic me/ranei hei kaiwhakarewa mo te tuku tuku-whakahaere, a he taonga whakamarumaru antimicrobial i te wa e tika ana te kukume.Ko te nui o te Betadex Sulfobutyl Ether Sodium ka taea te whakamahi ka whakawhirinaki ki te kaupapa mo te whakauru ki roto i te waihanga, te huarahi whakahaere, me te kaha o te cyclodextrin ki te uaua me te rongoa e tukuna ana.
Ko te Betadex Sulfobutyl Ether Sodium i ahu mai i te b-cyclodextrin, he nephrotoxic i te wa e tukuna ana ma te matua.Heoi ano, kua kitea e nga rangahau he pai te manawanui o te sulfobutylether bcyclodextrin i nga pota teitei, ina tukuna ma te werohanga bolus, ma te waha, ma te whakangohanga.Tae atu ki te 9 g ia ra ka tukuna ma te whaowhia IV i roto i te waihanga voriconazole whai raihana.Kei te tirotirohia te haumarutanga i muri i nga horopeta teitei o te sulfobutylether β-cyclodextrin ki roto i te tangata.Ko te Betadex Sulfobutyl Ether Sodium kua tukuna ki te pākahiko nui o te in vitro me te in vivo genotoxicity me nga arotake rongoa.Karekau he huringa genotoxic, mutagenic ranei i kitea ki te whakahaeretanga o te Betadex Sulfobutyl Ether Sodium.Ko te Betadex Sulfobutyl Ether Sodium he mea koiora, kaore he mahi rongoa.Ka tere te whakakorehia i te wa e tukuna ana ki roto.
Ko te Betadex Sulfobutyl Ether Sodium kei roto i te IV me te IM injectable hua kua whakaaetia inaianei me te hokohoko i nga USA, Europe, me Japan.Kei roto i te FDA Inactive Ingredients Database mo te whakamahi IM me te IV.Ko tana whakamahi i etahi atu huarahi, tae atu ki te SC, te waha, te inhalation, te nasal me te ophthalmic, kei te aromatawaihia i roto i nga rangahau haumanu.
Ma te whakamahi i te β-cyclodextrin me te 1,4-sulfobutyrolactone hei rauemi mata, ma te whakauru i te nui o te whakarewa pararopi e tika ana ki roto i te wairewa wai kawakore, ka piki ake te whakarewatanga o te 1,4-sulfobutyrolactone, me te hua whakahiato o te sulfobutyl ether-β-cyclodextrin. kua pai ake;Ko te otinga hua kua whiwhihia ka tukuna ki te dialysis ultrasonic, te whakakorenga waro whakahohe, te whakamaroke whakamaroke me etahi atu mahi kia whiwhi hua paura sulfobutyl ether-β-cyclodextrin.
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