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磺丁基倍他环糊精钠,Dexolve,SULFOBUTYLATED BETA-CYCLODEXTRIN SODIUM SALT (DS~6.5) 磺丁基-β-环糊精

Cyclolab生产的磺丁基倍他环糊精钠(注射级、超纯,Dexolve™)以cGMP条件下可年产12000kg(超过100公斤/批),在美国FDA的DMF备案号:21922。 Cyclolab磺丁基醚倍他环糊精钠(供注射用),无里程碑付款,无追加收费,无原研专利排他限制!目前已应用于以下制剂项目如:伏立康唑、卡非佐米、索非布韦、甲磺酸齐拉西酮、马罗吡坦、阿立哌唑、泊沙康唑、卡马西平、左旋苯丙氨酸氮芥等40多种注射剂。 磺丁基倍他环糊精钠(SBECD)为白色粉末,无臭无毒微甜,高水溶性。作为一种赋形剂主要用于含氮类药物中。也可作为增溶剂、润湿剂、螯合剂(络合剂)、多价掩蔽剂。 SBECD是阴离子型高水溶性环糊精衍生物,能很好地与药物分子包合形成非共价复合物,从而提高药物的稳定性、水溶性、安全性、降低肾毒性、缓和药物溶血性、控制药物释放速率、掩盖不良气味等,目前已应用于注射药、口服药、鼻部用药、眼部用药,对于含氮类药物具有特殊的亲和力。

CAS No. : 182410-00-0
说明 : CDE登记号:F20190000489
级别 : 药用级 Pharma Grade
品名 : 磺丁基倍他环糊精钠,Dexolve,SBECD,磺丁基-β-环糊精,BETA-CYCLODEXTRIN-SULFOBUTYLETHER DERIVATIVE ,磺丁基醚倍他环糊精钠
产地 : 匈牙利
包装 : 10g/包装,50g/袋,1kg/袋,5kg/袋,7kg/袋
CHEMICAL AND PHYSICAL DESCRIPTION
Average Molecular FormulaC42H70-nO35 · (C4H8O3SNa)n
Average Formula Weight1135.0 + n·(158.2)
Possible impurities4-Hydroxybutane-1-sulfonic acid sodium salt, bis(4-sulfobutyl) ether disodium, residual beta-cyclodextrin
Solubility
(in 100 cm3 solvent, at 25 °C)
Water: > 50 g
Methanol: < 0.5 g
Acetone: < 0.5 g
SPECIFICATION
TestMethodRange
AppearanceVisualwhite or off-white powder
Identification AIR (USP<197>, EP 2.2.24)complies with SBECD reference
Identification BHPLC (USP<621>, EP 2.2.29)tR of major peak complies with SBECD reference
Identification CCE (USP<1053>, EP 2.2.47)Average Degree of Substitution: 6.2 - 6.9
Identification DSodium ID (USP<191>, EP 2.3.1)positive test
AssayHPLC (USP<621>, EP 2.2.29)95.0 - 105.0% on the anhydrous basis
Heavy metalsICP-MS (USP<232, 233="">Cadmium  NMT 0.5 µg/g
Lead  NMT 0.5 µg/g
Arsenic  NMT 1.5 µg/g
Mercury  NMT 3.0 µg/g
Chromium  NMT 110 µg/g
Nickel  NMT 2 µg/g
Molybdenium  NMT 150 µg/g
Vanadium  NMT 1 µg/g
Limit of related substances
beta-cyclodextrin (Betadex)
total other impurities
HPLC (USP<621>)
NMT 0.1%
NMT 1.0%
Limit of 1,4-Butane SultoneGC (USP<621>)NMT 0.5 ppm
Limit of Sodium ChlorideLimit test (USP<221>)NMT 0.2%
Limit of 4-Hydroxybutane-1-sulfonic AcidCE (USP<1053>)NMT 0.09%
Limit of Bis(4-sulfobutyl) Ether DisodiumCE (USP<1053>)NMT 0.05%
Bacterial Endotoxin TestEP-USP harmonized method≤ 24 IU/g
Microbial Enumeration TestsEP-USP harmonized methodTAMC ≤ 100 cfu/g
TYMC ≤ 50 cfu/g
Test for Specified MicroorganismEP-USP harmonized methodabsence of Escherichia Coli /1 g
Phosphate contentUV-Vis Spectroscopy (USP<851>, EP 2.2.25)525-700 μg/g
Clarity of solution (30%, w/v)Visual, see details in the USP Monograph, the solution is clear, and essentially free from particles of foreign matter
Clarity of solution (15%, w/v)EP 2.2.1the solution is clear and colorless
Average Degree of Substitution (n)NMR (EP 2.2.33)5.9 - 6.6
Average Degree of Substitution (n)CE (USP<1053>6.2 - 6.9
Peak distributionCE (USP<1053>, EP 2.2.47)each SBECD peak (I-X) meets the limit range (peak area %) of the Monograph

SBECD sodium                  Limit range
peaks                                (% peak area)

I (DS-1)                                 0 - 0.3
II (DS-2)                                0 - 0.9
III (DS-3)                               0.5 - 5.0
IV (DS-4)                              2.0 - 10.0
V (DS-5)                               10.0 - 20.0
VI (DS-6)                              15.0 - 25.0
VII (DS-7)                             20.0 - 30.0
VII (DS-8)                             10.0 - 25.0
IX (DS-9)                              2.0 - 12.0
X (DS-10)                             0 - 4.0
Residual solvents: ethanolGC (USP<621>, EP 2.2.28)NMT 2500 ppm
pH (30%, w/V)USP<791>4.0 - 6.8
pH (15%, w/V)EP 2.2.35.0 -7.5
Impurities 
IMP A (BCD)
IMP C (HOBSA)
IMP D (DIBSA
HPLC  (EP 2.2.29)
max. 0.1%
max. 0.1%
max. 0.05%
 
IMP B (1,4-BS)GC (EP 2.2.28)max 0.5 ppm
Reducing sugarsUV-VIS (EP 2.2.25)max. 0.05%
Water contentUSP<921>Method I, EP 2.5.12NMT 10.0 %

Storage: at room temperature, in tightly closed container. 

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