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 mgbe n = 6.5
beta cyclodextrin sulfobutyl ethers, sodium salts;
Beta cyclodextrin sulfobutyl ether sodium [182410-00-0].
Nkọwa
A na-akwado Betadex Sulfobutyl Ether Sodium site na alkylation nke betadex site na iji 1,4-butane sultone n'okpuru ọnọdụ ndị bụ isi.
Nkezi ogo nke nnọchi na betadex bụ NLT 6.2 na NMT 6.9.
Ọ nwere NLT 95.0% na NMT 105.0% nke C42H70-nO35 · (C4H8SO3Na) n (n = 6.2-6.9), gbakọọ na anhydrous ndabere.
Nchọpụta
• A. INFRARED ABSORPATION <197K>
• B. Oge njide nke isi ọnụ ọgụgụ kachasị elu nke ngwọta Sample dabara na nke ọkọlọtọ ọkọlọtọ, dị ka enwetara na Assay.
• C. Ọ na-emezu ihe achọrọ maka ule maka Nkezi Degree nke nnọchi.
• D. Nnwale MMADỤ-General, Sodium 〈191〉
ASSAY
• Usoro
Usoro mkpanaka: 0.1M potassium nitrate na ngwakọta nke acetonitrile na mmiri (1: 4)
Ngwọta ọkọlọtọ: 10 mg/mL nke USP Betadex Sulfobutyl Ether Sodium RS na usoro mkpanaka.
Ngwọta nlele: 10 mg/mL nke Betadex Sulfobutyl Ether Sodium na usoro mkpanaka
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: LC
Nchọpụta: Ntụgharị uche
Ọnọdụ ihe nchọpụta: 35 ± 2°
Ogidi: 7.8-mm × 30-cm kọlụm nyocha;mbukota L37.[IHE-Sachapụ kọlụm ahụ na ngwọta nke acetonitrile na mmiri (1: 9) na mmecha nke usoro ịgba ọsọ.]
Ọnụego mmiri: 1.0 ml / min
Nha igba ogwu: 20µL
Sistemu kwesịrị ekwesị.
Ihe atụ: Ngwọta ọkọlọtọ
Kwesịrị ekwesị chọrọ
Ngbanwe ọkọlọtọ emetụtara: NMT 2.0%
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent nke betadex sulfobutyl ether sodium [C42H70-nO35 · (C4H8SO3Na) n] na akụkụ nke Betadex Sulfobutyl Ether Sodium were:
Nsonaazụ = (rU/rS) × (CS/CU) × 100
rU = nzaghachi kacha elu maka betadex sulfobutyl ether
sodium si sample ngwọta
rS = nzaghachi kacha elu maka betadex sulfobutyl ether
sodium si Standard ngwọta
CS = ntinye uche nke USP Betadex Sulfobutyl Ether
Sodium RS na ngwọta ọkọlọtọ (mg/mL)
CU = ntinye nke Betadex Sulfobutyl Ether Sodium na ngwọta nlele (mg/mL)
Usoro nnabata: 95.0% ~ 105.0% na ndabere anhydrous
IHE adịghị ọcha
• Ọla dị arọ, Usoro II <231>: NMT 5 ppm
OKWU BETA CYCLODEXTRIN (BETADEX)
Ngwọta A: 25 mm sodium hydroxide
Ngwọta B: 250 mm sodium hydroxide na 1M potassium nitrate
Usoro mkpanaka: Lee Tebụl 1.
Tebụl 1

Ngwọta ọkọlọtọ: 2 μg/ml nke USP Beta Cyclodextrin RS
Ngwọta nlele: 2 mg/mL nke Betadex Sulfobutyl Ether Sodium
Sistemụ chromatographic
(Lee Chromatography <621>, Ndabara Sistemu na Ion Chromatography <1065>.)
Ụdị: IC
Onye nchọpụta: amperometry pulsed (cell amperometric nwere electrode na-arụ ọrụ ọla edo na electrode ọlaọcha)
Ogidi
Nchekwa: 4.0-mm × 5-cm mgbanwe anion;mbukota L61
Nyocha: 4.0-mm × 25-cm mgbanwe anion;
mbukota L61
Okpomọkụ kọlụm: 50 ± 2°
Ọnụego mmiri: 1.0 ml / min
Nha igba ogwu: 20µL
Waveform maka ihe nchọpụta amperometric pulsed: Lee Tebụl 2.
Tebụl 2

Sistemu kwesịrị ekwesị
Ihe atụ: Ngwọta ọkọlọtọ
Kwesịrị ekwesị chọrọ
Ngbanwe ọkọlọtọ emetụtara: NMT 5.0%
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasenti beta cyclodextrin (betadex) na akụkụ nke Betadex Sulfobutyl Ether Sodium were:
Nsonaazụ = (rU/rS) × (CS/CU) × F × 100
rU = nzaghachi kacha elu maka beta cyclodextrin sitere na ngwọta nlele
rS = nzaghachi kacha elu maka beta cyclodextrin sitere na ngwọta ọkọlọtọ
CS = ntinye uche nke USP Beta Cyclodextrin RS na ngwọta ọkọlọtọ (µg/mL)
CU = ntinye nke Betadex Sulfobutyl Ether Sodium na ngwọta nlele (mg/mL)
F = ihe ntụgharị (10-3 mg/µg)
Usoro nnabata: NMT 0.1%
• Mbelata nke 1,4-BUTANE SULTONE
Ihe ngwọta dị n'ime: 0.25 μg/ml nke diethyl sulfone
Ọkọlọtọ ngwaahịa ngwọta A: 0.5 µg/mL nke 1,4-butane sultone
Standard ngwaahịa ngwọta B: 1.0 µg/ml nke 1,4-butane sultone
Ọkọlọtọ ngwaahịa ngwọta C: 2.0 µg/mL nke 1,4-butane sultone
Ngwọta ihe atụ: 250 mg/mL nke Betadex Sulfobutyl Ether Sodium na ngwọta dị n'ime.
Ngwọta oghere, yana Ngwọta Nlereanya A, B, C, na D:
Soro Tebụl 3 ka idowe ọnụọgụ nke ngwọta ọkọlọtọ Internal, ngwọta ngwaahịa ọkọlọtọ ọ bụla, ngwọta ngwaahịa, mmiri, ma ọ bụ methylene chloride n'ime tube ule iko ọ bụla nwere nkwụsị.[NOTE-A screw-capped, 10-mL test tube kwesịrị ekwesị.] Gwakọta na mixer vortex tube ule ọ bụla maka 30 s, ma kwe ka o guzoro ma ọ dịkarịa ala 5 min ma ọ bụ ruo mgbe nkewa zuru oke nke usoro ahụ.Wepụ akụkụ ahụ organic n'ime vial GC na akara.[IHE-Site na nnukwu nlezianya were opekempe nke usoro mmiri nwere ike ime.] Ọnụego 1,4-butane sultone agbakwunyere na Sample Solution A, B, C, na D bụ 0.5, 1.0, 2.0, na 0 μg, n'otu n'otu.
Tebụl 3

[IHE- Kwadebe ozugbo tupu ojiji.]
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: GC
Ihe nchọpụta: ionization ọkụ
Ogidi: 0.32-mm × 25-m fused-silica capillary kọlụm;0.5-µm oyi akwa nke G46
Okpomọkụ
Ihe nchọpụta: 270°
ọdụ ụgbọ mmiri ịgbanye: 200°
Kọlụm: Hụ mmemme okpomọkụ na tebụl 4
Tebụl 4
Okpomọkụ izizi (°) Mgbago okpomọkụ (°/min) Okpomọkụ ikpeazụ (°) Jide oge na okpomọkụ ikpeazụ (min)
100 10 200 -
200 35 270 5
Carrier gas: Helium, ọ na-adịkarị na nrụgide mbata 12 psi
Nha igba ogwu: 1.0µL
Ụdị ịgba ọgwụ: injection na-enweghị nkewa maka 0.5 min, wee kewaa na 50 ml / min.[IHE-A na-atụ aro iji eriri injection na-enweghị nkewa kwesịrị ekwesị.]
Sistemu kwesịrị ekwesị
Ọmụmaatụ: Ngwọta sample B
[IHE-Oge njide ikwu maka diethyl sulfone na 1,4-butane sultone bụ 0.7 na 1.0, n'otu n'otu.]
Kwesịrị ekwesị chọrọ
Ọkọlọtọ emetụtara: NMT 10.0%
Nyocha
Nlereanya: Ngwọta oghere, Ngwọta nlele A, B, C, na D
Dezie nha nke nzaghachi kacha elu nke 1,4-butane sultone na diethyl sulfone na Sample Solution A, B, C, ma ọ bụ D site na ibelata oke nzaghachi kacha elu nke 1,4-butane sultone na ethyl sulfone na oghere oghere. .Chee atụmatụ nhazi nke nzaghachi kacha elu nke 1,4-butane sultone maka nzaghachi kacha elu nke diethyl sulfone na Sample Solution A, B, C ma ọ bụ D, yana ọnụọgụ agbakwunyere, na µg, nke 1,4-butane sultone.Wepụ ahịrị iji jikọta isi ihe dị na eserese ahụ ruo mgbe ọ ga-ezute oke axis.Ebe dị n'etiti ebe a na nkwụsị nke axes na-anọchi anya ọnụọgụ 1,4-butane sultone, A, na µg, na akụkụ 4-mL nke ngwọta ngwaahịa Sample.Gbakọọ ọdịnaya nke 1,4-butane sultone na akụkụ nke Betadex Sulfobutyl Ether Sodium were:
Nsonaazụ = A/(VExt × CU × F)
A = kpebisiri ike n'elu
VEXt = olu nke ihe ngwọta ngwaahịa Sample ejiri na nzọụkwụ mmịpụta, 4.0 ml
CU = ntinye nke Betadex Sulfobutyl Ether Sodium n'ime ihe ngwọta ngwaahịa (mg/mL)
F = ihe ntụgharị (10-3 g/mg)
Usoro nnabata: hydroxybutane-1-sulfonic acid, ma ọ bụ NMT 0.5 ppm
• OKWU SODIUM CHLORIDE, 4-HYDROXYBUTANE-1-SULFOIC ACID, NA BIS (4-SULFOBUTYL) ETHER DISODIUM.
Ngwọta A: 5 mM sodium hydroxide, degas na arịa mechiri emechi maka 15 min
Ngwọta B: 25 mM sodium hydroxide, degas na arịa mechiri emechi maka 15 min
Usoro mkpanaka: Lee Tebụl 5
Tebụl 5

Ngwọta ịsacha kọlụm A: 50 mM sodium citrate
Ngwọta ịsacha kọlụm B: 150 mm sodium hydroxide
Ọkọlọtọ ngwọta: Kwadebe ngwọta na-amata ọkwa nke 8 µg/mL nke USP Sodium Chloride RS, 4µg/mL nke 4-hydroxybutane-1-sulfonic acid, na 4 μg/mL nke bis (4-sulfobutyl) ether disodium.
Ngwọta nlele: 4 mg/mL nke Betadex Sulfobutyl Ether Sodium
Sistemụ chromatographic
(Lee Chromatography <621>, Ndabara Sistemu na Ion Chromatography <1065>.)
Ụdị: IC
Nchọpụta: Omume
Oke: 30µS
Ugbu a: 100mA
Kọlụm: [MARA-N'ọgwụgwụ nke ọ bụla na-agba ọsọ, hichaa kọlụm site na iji kọlụm na-asacha ngwọta A na ọnụego 1 mL / min maka 35 min wee jiri kọlụm na-asacha ngwọta B n'otu ọsọ ọsọ maka 35 min.]
Nchekwa: 4.0-mm × 5.0-cm mgbanwe anion;mbukota L61
Nyocha: 4.0-mm × 25-cm mgbanwe anion;mbukota L61
Okpomọkụ kọlụm: 30°
Suppressor: Micromembrane anion autosuppressor1 ma ọ bụ sistemu mbelata kemịkalụ dabara adaba
Onye na-egbochi: mgbochi akpaaka
Ọnụego mmiri: 1.0 ml / min
Nha igba ogwu: 20µL
Sistemu kwesịrị ekwesị
Ihe atụ: Ngwọta ọkọlọtọ
[MGBAKWUO-A na-enye oge njigide ndị ikwu naanị maka ozi.Oge njide ikwu maka 4-hydroxybutane-1-sulfonate ion, ion chloride, na bis (sulfobutyl) ether ion bụ 1.0, 1.4, na 8.6, n'otu n'otu.]
Kwesịrị ekwesị chọrọ
Mkpebi: NLT 2.0
Ọkọlọtọ emetụtara: NMT 10.0%
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent sodium chloride, 4-hydroxybutane-1-sulfonic acid, ma ọ bụ bis(sulfobutyl) ether disodium na akụkụ nke Betadex Sulfobutyl Ether Sodium were:
Nsonaazụ = (rU/rS) × (CS/CU) × F × 100
rU = nzaghachi kacha elu maka sodium chloride, 4-hydroxybutane-1-sulfonic acid, ma ọ bụ bis (sulfobutyl) ether disodium sitere na ngwọta nlele.
rS = nzaghachi kacha elu maka sodium chloride, 4-hydroxybutane-1-sulfonic acid, ma ọ bụ bis (sulfobutyl) ether disodium sitere na ngwọta ọkọlọtọ.
CS = ntinye nke sodium chloride, 4-hydroxybutane-1-sulfonic acid, ma ọ bụ bis (sulfobutyl) ether disodium na ngwọta ọkọlọtọ (µg/mL)
CU = ntinye nke Betadex Sulfobutyl Ether Sodium na ngwọta nlele (mg/mL)
F = ihe ntụgharị (10-3 0 100 0 mg/µg)
Usoro nnabata
Sodium chloride: NMT 0.2%
4-Hydroxybutane-1-sulfonic acid: NMT 0.09%
Bis (sulfobutyl) ether disodium: NMT 0.05%
Nnwale akọwapụtara
Nnwale BACTERIAL ENDOTOXINS <85>: Ọkwa nke nje bacteria endotoxins bụ na enwere ike izute ihe achọrọ n'okpuru ụdị usoro onunu ogwu dị mkpa nke ejiri Betadex Sulfobutyl Ether Sodium mee ihe.Ebe akara ahụ na-ekwu na Betadex Sulfobutyl Ether Sodium ga-edozirịrị nhazi ọzọ n'oge nkwadebe nke ụdị ọgwụgwọ injectable, ọkwa nke endotoxins nke nje bụ na ihe a chọrọ n'okpuru ụdị usoro onunu ogwu dị mkpa nke a na-eji Betadex Sulfobutyl Ether Sodium. enwere ike zute.
• microbial na-ahụ maka emepụta <61> na ule maka microorganisms akọwapụtara <62>: Ngụkọta Arobic County erughị 100 CFU / GULSE jikọtara ọnụ erughị 50 CFU / g.Ọ na-emezu ihe achọrọ maka ule maka enweghị Escherichia coli.
• OKWU OKWU OKWU
Ngwọta nlele: 30% (w/v) ngwọta
Nyocha: Nyochaa ihe ngwọta ahụ site na iji igbe ọkụ megide nzụlite ọcha na ojii, wee dekọọ ọnụnọ nke haze, fluorescence, eriri, specks, ma ọ bụ ihe mba ọzọ ọ bụla.
Usoro nnabata: Ngwọta ahụ doro anya, ma bụrụ nke na-enweghị isi na akụkụ nke ihe mba ọzọ.
• Ọkara ogo nke nnọchi
Gbaa electrolyte: 30 mM benzoic acid ma gbanwee na pH nke dabara maka ngwa eji agbakwunyere 100 mM tris (hydroxymethyl) aminomethane buffer.
[IHE-N'ihi mgbanwe dị n'etiti capillaries, akọwapụtaghị otu pH electrolyte na-emetụta ụwa niile.
Kama nke ahụ, a ga-ekpebi pH kacha mma jikọtara ya na capillary nke ọ bụla dị ka akwụkwọ ntuziaka ngwá ọrụ si dị.]
Ngwọta ọkọlọtọ: 10 mg/mL nke USP Betadex Sulfobutyl Ether Sodium RS
Ngwọta nlele: 10 mg/mL nke Betadex Sulfobutyl Ether Sodium
Usoro ikpochapu Capillary: Jiri vial electrolyte na-agba ọsọ dị iche iche maka ịsacha capillary na nyocha nlele.Mee nyocha tupu nyocha kwa ụbọchị tupu nyocha nke ọ bụla: kpochaa capillary na 0.1 N sodium hydroxide maka 30 min, na mmiri maka NLT 2 h, na Run electrolyte maka NLT 1 h.Mee rinses tupu injection tupu ịgba ọgwụ ọ bụla dị ka ndị a.Jiri 0.1 N sodium hydroxide sachaa capillary maka NLT 1 min, na jiri Run electrolyte maka NLT 3 min.Ọ bụrụ na a na-eji capillary ọhụrụ eme ihe, na mgbakwunye na rinses mgbe niile a kọwara n'elu, capillary ọhụrụ chọrọ ịsacha tupu ojiji mbụ ya.Jiri 1 M sodium hydroxide sachaa capillary ọhụrụ maka awa 1, wee sachaa mmiri 2-h.
Sistemụ electrophoretic
(Lee Capillary Electrophoresis <1053>.)
Ụdị: CE dị elu
Nchọpụta: Inverse UV 200 nm, yana bandwit nke 20nm.[IHE-A ga-eji ogologo oge nchọpụta 205 nm nwere bandwit nke 10 nm dị ka ihe ọzọ.]
Ogidi: Sodium ọnụ ọnụ I–X (% Mpaghara kacha elu) 50-µm × 50-cm kọlụm silica agwakọtara
Okpomọkụ kọlụm: 25°
Ngwa ọkụ etinyere: 0.00 ruo + 30.00 kV linear ramp n'elu 10 min, wee na 30 kV maka nkeji 20 ọzọ.
Nha ịgba ọgwụ: nha nha nha na 0.5 psi maka s 10
Sistemu kwesịrị ekwesị
Ihe atụ: Ngwọta ọkọlọtọ
[MARA-Lee Tebụl 6 maka oge mbịambịa dị nso maka betadex sulfobutyl ether sodium ọnụ ọnụ I-X (betadex sulfobutyl ether sodium peaks I, II, III, ..., X, nwere beta cyclodextrin molecule nwere 1, 2, 3, ..., 10 sulfobutyl nnọchi(s), n'otu n'otu).Oge mbugharị ndị ikwu bụ maka ebumnuche ozi naanị iji nyere aka na njirimara kacha elu.]
Tebụl 6

Kwesịrị ekwesị chọrọ
Mkpebi: NLT 0.9, n'etiti betadex sulfobuty ether sodium peak IX na betadex sulfobutyl ether sodium kasị elu X.
Nyocha
Sample: Gbaa electrolyte, mmiri, Ọkọlọtọ ngwọta na Sample ngwọta
Tinye ihe ngwọta Standard na ihe ngwọta Sample site n'itinye nrụgide dị iche iche nke 0.5 psi, nke kwekọrọ na 34 mbar, maka 10 s, na-esote injection nke Run electrolyte na 0.5 psi maka 2 s.[Ekwesịrị iji vial mmiri mee injections-nrụgide ma ọ bụ Gbaa electrolyte na ngwụcha ngwụcha nke capillary.]
Dekọọ electropherograms, wee tụọ nzaghachi kacha elu maka betadex sulfobutyl ether sodium peaks (I ruo X).Gbakọọ mpaghara kacha elu emeziri, AI, maka ọnụ ọgụgụ kacha elu nke ọ bụla na eletropherogram:
Mpaghara kacha elu emeziri A = Mpaghara kacha elu x Ogologo Capillary dị irè (cm) / Oge Mbugharị
Hazie mpaghara ọnụ ọgụgụ kacha elu emeziri site n'igosi nke ọ bụla dị ka pasentị nke mkpokọta ngbanwe mpaghara envelopu emeziri:
Mpaghara akpọrọ aha, NA: A / n∑i=1 Ai x 100
n = ọkwa kachasị elu nke nnọchi
Kpebie nkezi ogo nnọchi anya:
Nkezi ogo nke nnọchi = n∑i=1 (Ọkwa nke nnọchi maka ọnụ ọgụgụ kasị elu x NA) / 100
Usoro nnabata: 6.2~6.9 maka nkezi ogo nnọchi anya
Maka nke ọ bụla n'ime betadex sulfobutyl ether sodium ọnụ ọnụ I-X, lee oke oke (% mpaghara kacha elu) na Tebụl 7.
Tebụl 7

• PH <791>: 4.0-6.8, na ngwọta 30% (w / v) na mmiri na-enweghị carbon dioxide.
• Mkpebi mmiri, Usoro I <921>: NMT 10.0%
NKWUO GBASARA YA
• Nkwakọba na Nchekwa: Chekwaa n'ime akpa mechiri emechi nke ọma, na-echekwa na ụlọ okpomọkụ.Chebe site na mmiri mmiri.
• Ịkpọ aha: Kpọọ ya aha iji gosi ojiji ọ na-emepụta ụdị ọgwụ injectable.
• Ụkpụrụ ntụaka USP <11>
USP Beta Cyclodextrin RS
USP Betadex Sulfobutyl Ether Sodium RS
USP Endotoxin RS
USP Sodium Chloride RS■1S (NF30)