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 inā n = 6.5
Beta cyclodextrin sulfobutyl ethers, nā paʻakai sodium;
Beta cyclodextrin sulfobutyl ether sodium [182410-00-0].
HOAKAKA
Hoʻomākaukau ʻia ʻo Betadex Sulfobutyl Ether Sodium e ka alkylation o betadex me ka hoʻohana ʻana i ka sultone 1,4-butane ma lalo o nā kūlana kumu.
ʻO ka pae awelika o ka hoʻololi ʻana i ka betadex ʻo NLT 6.2 a me NMT 6.9.
Loaʻa iā NLT 95.0% a me NMT 105.0% o C42H70−nO35 · (C4H8SO3Na)n (n = 6.2–6.9), helu ʻia ma ke kumu anhydrous.
IKE
• A. KA PALAPALA INFRARED <197K>
B. ʻO ka manawa paʻa o ke kiʻekiʻe nui o ka hāʻina Sample e pili ana i ka hopena maʻamau, e like me ka loaʻa ʻana ma ka Assay.
• C. Ua kūpono ia i nā koi o ka ho'āʻo no ka Average Degree of Substitution.
• D. HO'O'O'O'O NO KA HO'O'A'A-MA'I, Sodium 〈191〉
HANA
• HANA
ʻĀpana paʻa: 0.1 M potassium nitrate i ka hui ʻana o ka acetonitrile a me ka wai (1:4)
Haʻina maʻamau: 10 mg/mL o USP Betadex Sulfobutyl Ether Sodium RS ma ka pae Mobile
Laʻana hoʻonā: 10 mg/mL o Betadex Sulfobutyl Ether Sodium ma ka pae Mobile
Pūnaehana Chromatographic
(E nana Chromatography <621>, Pūnaehana Pono.)
Ke ano: LC
Mea ʻimi: ʻIdeka Refractive
ʻIke wela: 35 ± 2°
kolamu: 7.8-mm × 30-cm kolamu analytical;kāʻei L37.[MAKEMAKE-E holoi i ke kolamu me ka hopena o ka acetonitrile a me ka wai (1:9) i ka pau ana o ka holo ana.]
Kahe kahe: 1.0 mL / min
Ka nui o ka hoʻopio: 20 µL
Kūpono ʻōnaehana .
Laʻana: Haʻina maʻamau
Nā koi kūpono
Wehewehe maʻamau pili: NMT 2.0%
Kānāwai
Nā Laʻana: Haʻina maʻamau a me ka hāʻina Laʻana
E helu i ka pākēneka o ka sodium betadex sulfobutyl ether [C42H70−nO35 · (C4H8SO3Na)n] i loko o ka hapa o Betadex Sulfobutyl Ether Sodium i lawe ʻia:
Ka hopena = (rU/rS) × (CS/CU) × 100
rU = pane kiʻekiʻe no ka betadex sulfobutyl ether
ka sodium mai ka hāpana Laʻana
rS = pane kiʻekiʻe no ka betadex sulfobutyl ether
ka sodium mai ka hoʻonā maʻamau
CS = ka manaʻo o ka USP Betadex Sulfobutyl Ether
ʻO ka sodium RS i ka hopena maʻamau (mg/mL)
CU = ka hoʻopaʻa ʻana o Betadex Sulfobutyl Ether Sodium i loko o ka Haʻina Haʻawina (mg/mL)
Nā pae hoʻohālikelike: 95.0% ~ 105.0% ma ke kumu anhydrous
NA mea haumia
• NA METAL HEAVY, Hana II <231>: NMT 5 ppm
• LIMIT O BETA CYCLODEXTRIN (BETADEX)
Pane A: 25 mM sodium hydroxide
Pane B: 250 mM sodium hydroxide a me 1 M potassium nitrate
Hana paʻalima: E nānā i ka Papa 1.
Papa 1

Haʻina maʻamau: 2 µg/mL o USP Beta Cyclodextrin RS
Laʻana hoʻonā: 2 mg/mL o Betadex Sulfobutyl Ether Sodium
Pūnaehana Chromatographic
(E nana Chromatography <621>, System Suitability and Ion Chromatography <1065>.)
Ke ano: IC
ʻIke: Pulsed amperometry (amperometric cell me ke gula hana uila a me ke kālā kuhikuhi electrode)
kolamu
Kiaʻi: 4.0-mm × 5-cm hoʻololi anion;kāʻei L61
Analytical: 4.0-mm × 25-cm anion-exchange;
kāʻei L61
Ka wela o ke kolamu: 50 ± 2°
Kahe kahe: 1.0 mL / min
Ka nui o ka hoʻopio: 20 µL
Ka hawewe no ka mea ike amperometric pulsed: E nana i ka Papa 2.
Papa 2

Kūpono ʻōnaehana
Laʻana: Haʻina maʻamau
Nā koi kūpono
Wehewehe maʻamau pili: NMT 5.0%
Kānāwai
Nā Laʻana: Haʻina maʻamau a me ka hāʻina Laʻana
E helu i ka pākēneka o ka beta cyclodextrin (betadex) ma ka hapa o Betadex Sulfobutyl Ether Sodium i lawe ʻia:
Ka hopena = (rU/rS) × (CS/CU) × F × 100
rU = pane kiʻekiʻe no ka beta cyclodextrin mai ka Haʻina Haʻawina
rS = pane kiʻekiʻe no ka beta cyclodextrin mai ka hopena maʻamau
CS = ka hoʻopaʻa ʻana o ka USP Beta Cyclodextrin RS i ka hoʻonā maʻamau (µg/mL)
CU = ka hoʻopaʻa ʻana o Betadex Sulfobutyl Ether Sodium i loko o ka Haʻina Haʻawina (mg/mL)
F = kumu hoʻololi (10-3 mg/µg)
Nā pae ʻae ʻae: NMT 0.1%
• LIMIT O 1,4-BUTANE SULTONE
Haʻina maʻamau i loko: 0.25 µg/mL o diethyl sulfone
Haʻina waihona waiwai A: 0.5 µg/mL o 1,4-butane sultone
Haʻina waihona maʻamau B: 1.0 µg/mL o 1,4-butane sultone
Haʻina waihona waiwai maʻamau C: 2.0 µg/mL o 1,4-butane sultone
Laʻana waihona waihona: 250 mg/mL o Betadex Sulfobutyl Ether Sodium i loko o ka hoʻonā maʻamau o loko.
Haʻina hakahaka, a me nā hāʻina laʻana A, B, C, a me D:
E hahai i ka Papa 3 e kau i ka nui o ka solution ma'amau o loko, kela me keia mea ho'ohehe'e ma'amau.[NOTE-He paipu ho'āʻo 10-mL i uhi ʻia.] E hoʻohui i kēlā me kēia paipu hoʻāʻo no 30 s, a ʻae iā ia e kū no ka liʻiliʻi he 5 min a i ʻole a hiki i ka kaʻawale ʻana o ka pae.Wehe i ka māhele organik i loko o kahi hue GC a sila.[NOTE-Me ka mālama nui, e lawe i ka liʻiliʻi loa o ka ʻāpana wai.] ʻO ka nui o ka sultone 1,4-butane i hoʻohui ʻia i loko o nā haʻina laʻana A, B, C, a me D he 0.5, 1.0, 2.0, a me 0 µg.
Papa 3

[NĀ MEA-E hoʻomākaukau koke ma mua o ka hoʻohana ʻana.]
Pūnaehana Chromatographic
(E nana Chromatography <621>, Pūnaehana Pono.)
Ke ano: GC
Mea ʻIke: Hoʻopā ahi
kolamu: 0.32-mm × 25-m fused-silica capillary kolamu;0.5-µm papa o ka māhele G46
Mahana
ʻIke: 270°
Ke awa hoʻokomo: 200°
Kolu: E nānā i ka papahana wela ma ka Papa 4
Papa 4
Mahana Hoʻomaka (°) Ramp Mahana (°/min) Mahana Hope (°) Manawa Paʻa i ka Mahana Hope (min)
100 10 200 -
200 35 270 5
Ke kinoea halihali: Helium, maʻamau ma 12 psi inlet kaomi
Ka nui o ka hoʻopio: 1.0 µL
ʻAno hoʻoheheʻe: ʻoki ʻole ʻia no 0.5 min, a laila hoʻokaʻawale i 50 mL/min.[NĀ MEA-Ua paipai ʻia ka hoʻohana ʻana i kahi liner injection splitless kūpono.]
Kūpono ʻōnaehana
Laʻana: Laʻana hoʻonā B
[NOTE-ʻO nā manawa paʻa pili no ka diethyl sulfone a me ka 1,4-butane sultone he 0.7 a me 1.0.]
Nā koi kūpono
Wehewehe maʻamau pili: NMT 10.0%
Kānāwai
Nā Laʻana: Haʻina hakahaka, Nā hāʻina laʻana A, B, C, a me D
E hoʻoponopono i ka lakio o nā pane kiʻekiʻe o ka 1,4-butane sultone i diethyl sulfone ma ka hāʻina laʻana A, B, C, a i ʻole D ma ka unuhi ʻana i ka lakio o nā pane kiʻekiʻe o ka sultone 1,4-butane i ka ethyl sulfone i loko o ka solution Blank .E kahaki i ka lakio hoʻoponopono o ka pane kiʻekiʻe o 1,4-butane sultone i ka pane kiʻekiʻe o diethyl sulfone ma ka laʻana hoʻonā A, B, C a i ʻole D, me ka nui i hoʻohui ʻia, ma µg, o 1,4-butane sultone.E unuhi i ka laina e hui ana i na kiko ma ka pakuhi a hiki i ka halawai ana me ka nui axis.ʻO ka mamao ma waena o kēia kiko a me ka hui ʻana o nā koʻi e hōʻike ana i ka nui o ka sultone 1,4-butane, A, ma µg, ma ka ʻāpana 4-mL o ka hāpana waihona Laʻana.E helu i ka maʻiʻo o 1,4-butane sultone i ka ʻāpana o Betadex Sulfobutyl Ether Sodium i lawe ʻia:
Ka hopena = A/(VExt × CU × F)
A = i hoʻoholo ʻia ma luna
VExt = ka nui o ka hāʻina waihona laʻana i hoʻohana ʻia i ka ʻanuʻu unuhi, 4.0 mL
CU = ka hoʻopaʻa ʻana o Betadex Sulfobutyl Ether Sodium i loko o ka hāpana waihona Laʻana (mg/mL)
F = kumu hoʻololi (10-3 g/mg)
Nā pae hoʻohālikelike: hydroxybutane-1-sulfonic acid, a i ʻole NMT 0.5 ppm
• KA LIMIT O SODIUM CHLORIDE, 4-HYDROXYBUTANE-1-SULFONIC ACID, A me BIS(4-SULFOBUTYL) ETHER DISODIUM
Pane A: 5 mM sodium hydroxide, degas i loko o kahi ipu pani no 15 min
Pane B: 25 mM sodium hydroxide, degas i loko o kahi ipu pani no 15 min
Māhele kelepona: E nānā i ka Papa 5
Papa 5

ʻO ka wai holoi kolamu A: 50 mM sodium citrate
ʻO ka wai holoi kolamu B: 150 mM sodium hydroxide
Haʻina maʻamau: E hoʻomākaukau i ka hopena i ʻike ʻia he 8 µg/mL o USP Sodium Chloride RS, 4µg/mL o 4-hydroxybutane-1-sulfonic acid, a me 4 µg/mL o bis(4-sulfobutyl) ether disodium.
Laʻana hoʻonā: 4 mg/mL o Betadex Sulfobutyl Ether Sodium
Pūnaehana Chromatographic
(E nana Chromatography <621>, System Suitability and Ion Chromatography <1065>.)
Ke ano: IC
ʻIke: Conductivity
Laulā: 30 µS
ʻO kēia manawa: 100 mA
Kolume: [NOTE-Ma ka hopena o kēlā me kēia holo, hoʻomaʻemaʻe i ke kolamu me ka hoʻohana ʻana i ka wai holoi holoi Column A ma kahi kahe kahe o 1 mL/min no 35 min a laila hoʻohana i ka solution holoi holoi Column B ma ke kahe kahe like no 35 min.]
Kiaʻi: 4.0-mm × 5.0-cm anion-exchange;kāʻei L61
Analytical: 4.0-mm × 25-cm anion-exchange;kāʻei L61
Ka wela o ke kolamu: 30°
Kāohi: Micromembrane anion autosuppressor1 a i ʻole kahi ʻōnaehana hoʻopau kemika kūpono
Kāohi: Autosuppression
Kahe kahe: 1.0 mL / min
Ka nui o ka hoʻopio: 20 µL
Kūpono ʻōnaehana
Laʻana: Haʻina maʻamau
[NOTE-Hoʻolako ʻia nā manawa paʻa pili no ka ʻike wale nō.ʻO nā manawa paʻa pili no 4-hydroxybutane-1-sulfonate ion, chloride ion, a me bis(sulfobutyl) ether ion he 1.0, 1.4, a me 8.6.]
Nā koi kūpono
Hoʻoholo: NLT 2.0
Wehewehe maʻamau pili: NMT 10.0%
Kānāwai
Nā Laʻana: Haʻina maʻamau a me ka hāʻina Laʻana
E helu i ka pākēneka o ka sodium chloride, 4-hydroxybutane-1-sulfonic acid, a i ʻole bis(sulfobutyl) eter disodium i loko o ka hapa o Betadex Sulfobutyl Ether Sodium i lawe ʻia:
Ka hopena = (rU/rS) × (CS/CU) × F × 100
rU = pane kiʻekiʻe no ka sodium chloride, 4-hydroxybutane-1-sulfonic acid, a i ʻole bis(sulfobutyl) ether disodium mai ka hāpana Laʻana.
rS = pane kiʻekiʻe no ka sodium chloride, 4-hydroxybutane-1-sulfonic acid, a i ʻole bis(sulfobutyl) ether disodium mai ka hoʻonā maʻamau
CS = ka paʻa ʻana o ka sodium chloride, 4-hydroxybutane-1-sulfonic acid, a i ʻole bis(sulfobutyl) ether disodium i loko o ka hopena maʻamau (µg/mL)
CU = ka hoʻopaʻa ʻana o Betadex Sulfobutyl Ether Sodium i loko o ka Haʻina Haʻawina (mg/mL)
F = kumu hoʻololi (10−3 0 100 0 mg/µg)
Nā pae ʻae ʻae
ʻO ka sodium chloride: NMT 0.2%
4-Hydroxybutane-1-sulfonic acid: NMT 0.09%
Bis(sulfobutyl) etera disodium: NMT 0.05%
NA HOAO KUAI
BACTERIAL ENDOTOXINS TEST <85>: ʻO ke kiʻekiʻe o nā endotoxins bacteria e hiki ke hoʻokō ʻia ke koi ma lalo o ka (s) palapala hoʻohālikelike kūpono kahi i hoʻohana ʻia ai ka Betadex Sulfobutyl Ether Sodium.Ma kahi e ʻōlelo ai ka lepili e pono e hoʻokō hou ʻia ka Betadex Sulfobutyl Ether Sodium i ka wā o ka hoʻomākaukau ʻana i nā ʻano mea hoʻohana injectable, ʻo ke kiʻekiʻe o nā endotoxins bacteria e like me ke koi ʻana ma lalo o ka monograph (s) pili pono kahi i hoʻohana ʻia ai ka Betadex Sulfobutyl Ether Sodium. hiki ke halawai.
• KA HO'O'O IA MICROBIAL ENUMERATION <61> a me nā ho'ā'o no nā microorganism SPECIFIED <62>: ʻAʻole iʻoi aku ka nui o ka helu microbial aerobic ma mua o 100 cfu/g, a ʻaʻole ʻoi aku ka nui o nā mold a me nā huʻu i hui ʻia ma mua o 50 cfu/g.Hoʻokō ia i nā koi o ka hoʻāʻo no ka nele o Escherichia coli.
• KA MAKAA O KA PAPA
Haʻina haʻawina: 30% (w/v) solution
Nānā: E noʻonoʻo i ka hāʻina laʻana e hoʻohana ana i ka pahu kukui e pili ana i ke ʻano keʻokeʻo a me ka ʻeleʻele, a e hoʻopaʻa i ka loaʻa ʻana o nā haze, fluorescence, fiber, specks, a me nā mea ʻē aʻe.
Paʻa e ʻae ʻia: Ua akaka ka hopena, a ʻaʻole pono mai nā ʻāpana o nā mea ʻē.
• KA PALAPALA O KA PILI
Holo i ka electrolyte: 30 mM benzoic acid a hoʻololi ʻia i kahi pH kūpono no ka mea hana i hoʻohana ʻia me ka hoʻohui ʻana o 100 mM tris(hydroxymethyl) aminomethane buffer.
[NOTE-Ma muli o ka hoʻololi ʻana ma waena o nā capillaries, ʻaʻole i kuhikuhi ʻia kahi pH electrolyte pili honua.
Akā, pono e hoʻoholo ʻia ka pH maikaʻi loa e pili ana i kēlā me kēia capillary e like me ka manual instrumental.]
Haʻina maʻamau: 10 mg/mL o USP Betadex Sulfobutyl Ether Sodium RS
Laʻana hoʻonā: 10 mg/mL o Betadex Sulfobutyl Ether Sodium
ʻO ke kaʻina hana hoʻomaʻemaʻe capillary: E hoʻohana i nā hue electrolyte holo kaʻawale no ka holoi ʻana i nā capillary a me ka nānā ʻana.Hana i ka holoi ʻana ma mua o ka nānā ʻana i kēlā me kēia lā ma mua o kēlā me kēia loiloi: holoi i ka capillary me 0.1 N sodium hydroxide no 30 min, me ka wai no NLT 2 h, a me Run electrolyte no NLT 1 h.E hana i ka holoi ʻana ma mua o kēlā me kēia hoʻoheheʻe ʻana penei.Holoi i ka capillary me 0.1 N sodium hydroxide no NLT 1 min, a me Run electrolyte no NLT 3 min.Inā hoʻohana ʻia kahi capillary hou, ma waho aʻe o nā holoi maʻamau i hōʻike ʻia ma luna nei, pono kahi capillary hou e holoi ma mua o ka hoʻohana mua ʻana.Holoi i ka capillary hou me ka 1 M sodium hydroxide no 1 h, a ma hope o ka holoi wai 2-h.
Pūnaehana electrophoretic
(E nānā i ka Capillary Electrophoresis <1053>.)
Keʻano: CE hana kiʻekiʻe
ʻIke: Inverse UV 200 nm, me ka bandwidth o 20nm.[NOTE-Hiki ke hoʻohana ʻia kahi hawewe ʻike o 205 nm me kahi bandwidth o 10 nm ma ke ʻano he ʻokoʻa.]
Kona: Nā Puʻu Sodium I–X (% Area Peak) 50-µm × 50-cm kolamu silica fused
Ka wela o ke kolamu: 25°
Volta hoʻohana: 0.00 a +30.00 kV laina laina ma luna o 10 min, a laila ma 30 kV no kahi 20 min.
Ka nui o ka hoʻouka ʻana: Nā puke like ma 0.5 psi no 10 mau kekona
Kūpono ʻōnaehana
Laʻana: Haʻina maʻamau
[MAKEMAKE-E nānā i ka Papa 6 no nā manawa neʻe kokoke no ka betadex sulfobutyl ether sodium peaks I–X (betadex sulfobutyl ether sodium peaks I, II, III, ..., X, loaʻa ka molekala beta cyclodextrin me 1, 2, 3, ..., 10 sulfobutyl substituent(s), pakahi).No ka ʻike ʻike wale nō ka manawa o ka neʻe ʻana e kōkua i ka ʻike kiʻekiʻe.]
Papa 6

Nā koi kūpono
Hoʻoholo: NLT 0.9, ma waena o betadex sulfobuty ether sodium peak IX a me betadex sulfobutyl ether sodium peak X
Kānāwai
Nā Laʻana: Holo i ka electrolyte, ka wai, ka hoʻonā maʻamau, a me ka hāʻina Laʻana
E hoʻokomo i ka hāʻina maʻamau a me ka hāpana laʻana ma o ka hoʻohana ʻana i ke kaomi ʻokoʻa o 0.5 psi, e like me 34 mbar, no 10 s, a ukali ʻia me ka hoʻokomo ʻana o Run electrolyte ma 0.5 psi no 2 s.[NOTE-Pressure injections Pono e hana ʻia me kahi hue wai a i ʻole Run electrolyte ma ka hopena puka o ka capillary.]
E hoʻopaʻa i nā electropherograms, a e ana i nā pane kiʻekiʻe no kēlā me kēia betadex sulfobutyl ether sodium peaks (I a X).E helu i ka ʻāpana piko i hoʻoponopono ʻia, AI, no kēlā me kēia piko o ka eletropherogram:
Hoʻoponopono ʻia ʻo Peak Area A = Peak Area x Effective Capillary Length (cm) / Migration Time
E hoʻoponopono maʻamau i nā wahi kiʻekiʻe i hoʻoponopono ʻia ma ka hōʻike ʻana i kēlā me kēia ma ke ʻano he pākēneka o ka nui o nā wahi envelop hoʻololi i hoʻoponopono ʻia:
Wahi i koho ʻia, NA: A / n∑i=1 Ai x 100
n = kūlana kiʻekiʻe o ka hoʻololi
E hoʻoholo i ka degere awelika o ka hoʻololi:
ʻAwelika Degere o ka Hoʻololi ʻana = n∑i=1 (Ka pae o ka hoʻololi ʻana no ka Peak x NA) / 100
Nā pae hoʻohālikelike: 6.2 ~ 6.9 no ke degere awelika o ka hoʻololi
No kēlā me kēia betadex sulfobutyl ether sodium peaks I–X, e nānā i ka palena palena (% peak area) ma ka Papa 7.
Papa 7

• PH <791>: 4.0-6.8, i loko o kahi hoʻonā 30% (w/v) i loko o ka wai kalapona kalapona ʻole.
• KA HOʻOHAʻI O KA WAI, Ke ʻano I <921>: NMT 10.0%
NA KOI HOU
• PACKAGING a me ka mālama ʻana: mālama i loko o nā pahu paʻa maikaʻi, a mālama i ka lumi wela.Pale mai ka makū.
• LABELLING: Lepili iā ia e hōʻike i kona hoʻohana ʻana i ka hana ʻana i nā ʻano mea hoʻohana injectable.
• USP REFERENCE STANDARD <11>
USP Beta Cyclodextrin RS
USP Betadex Sulfobutyl Etera Sodium RS
USP Endotoxin RS
USP Sodium Chloride RS■1S (NF30)