产品描述
等级:活性药物成分(API)
化学名称:糖madex钠
分子式:C72H104Na8O48S8
分子量:2178.01000
规范:按照ChP/USP/EP建立企业标准
外观:粉
总杂质:不大于0.5%
纯度:不低于99%
残留溶剂:完全符合ICH Q3C要求
致突变杂质:完全符合ICH M8
亚硝胺评估:可用
粒度:可根据客户要求进行普通级或研磨/筛分。
储存方法:室温
生产能力:商用
标准包装:1kg/袋,5kg/袋,或根据客户要求
产品用途
糖madex钠是一种有机钠盐,是糖madex的八钠盐。用于逆转成人手术中罗库溴铵和维库溴铵引起的神经肌肉阻滞。它有神经肌肉剂的作用。它含有一个糖类(8-)。
为了方便气管插管、机械通气和手术通路,NMB药物经常被用作外科手术过程中的非麻醉辅助药物。Sugammadex能够作为罗库溴铵和维库溴铵(另一种非去极化神经肌肉阻滞剂)的药理学沉淀,没有直接与胆碱能系统相互作用的逆转剂所经历的心血管不良反应。γ-环糊精被设计为通过加入酸性侧链来促进与阻滞剂的正氮的静电相互作用来增强客体的结合。从γ-环糊精开始,这些侧链很容易安装,首先与碘或溴卤化,为在氢化钠存在下与3-巯基丙酸或3-巯基丙酸甲酯和碳酸铯进行亲核位移提供了一个处理。后者需要用氢氧化钠水解生成糖醛酸钠。
联系方式
四川青木制药有限公司
四川省眉山市东坡区经济开发区东区顺江大道南段55号
国际营销部(International):
Email: sales@eastonpharma.cn
Tel: 028-87827187
国内营销部(Mainland):
李经理 13880480517
杨经理 15982276454
Product Description
Grade: Active Pharmaceutical Ingredient(API)
Chemical Name: Sugammadex Sodium
Molecular Formula: C72H104Na8O48S8
Molecular Weight:2178.01000
Specification: Enterprise Standard established according to ChP/USP/EP
Appearance: Powder
Total impurities: not more than 0.5%
Purity: not less than 99%
Residual Solvents: fully comply with ICH Q3C
Mutagenic impurities: fully comply with ICH M8
Nitrosamine assessment: available
Particle size: regular grade or milling/sieving according to customer’s requirement.
Storage: Room temperature
Production capacity: Commercial
Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications
Sugammadex sodium is an organic sodium salt that is the octasodium salt of sugammadex. Used for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery. It has a role as a neuromuscular agent. It contains a sugammadex(8-).
To facilitate tracheal intubation, mechanical ventilation, and surgical access, NMB agents are frequently used as non-anesthetic adjuncts in surgical procedures. Sugammadex is able to function as a pharmacologic sink of rocuronium and vecuronium, another non-depolarizing neuromuscular blocker, without the cardiovascular adverse effects experienced with reversal agents that directly interact with the cholinergic system. The γ-cyclodextrin has been designed to enhance the binding of the guest by incorporating acidic side chains to promote an electrostatic interaction with the positive nitrogen of the blocker. Starting with γ-cyclodextrin, these side chains are readily installed by first halogenating with iodine or bromine to provide a handle for nucleophilic displacement with either 3-mercaptopropionic acid in the presence of sodium hydride or with 3-mercaptopropionic acid methyl ester and cesium carbonate. The latter requires hydrolysis with sodium hydroxide to generate sugammadex sodium.
Contact Information
Sichuan Qingmu Pharmaceutical Co., Ltd.
Add: No. 55, South Shunjiang Avenue, East Economic Development Zone, Dongpo District, Meishan City, Sichuan, 620036, China
International Marketing Department:
Email: sales@eastonpharma.cn
Tel: 0086-28-87827187
关键字: 舒更葡糖钠;Sugammadex sodium;舒更葡糖钠杂质;舒更葡糖钠(API);舒更葡糖钠标准品001;
四川青木制药有限公司(简称“青木制药”)成立于2011年,位于四川眉山,现有员工300余人,是一家专业从事特色原料药及高端医药中间体研发、生产与销售的高新技术企业,是成都苑东生物制药股份有限公司(简称“苑东生物”)的全资子公司。苑东生物成立于2009年,下设5家全资子公司,现有员工1100余人。苑东生物专注于麻醉镇痛、糖尿病、心血管、抗肿瘤等重大疾病领域,先后实现了20余个制剂产品和近20个化学原料药产品的产业化。公司于2020年9月在上海证券交易所科创板挂牌上市(股票代码:688513)。
研发优势:
1.QbD+绿色化学理念
2.中外双报
3.API晶型、工艺专利挑战经验
体系优势:
1.GMP体系健全:10次NMPA检查,1次美国FDA检查
2.符合欧/美/日GMP标准: 3*JDMF, 4*USDMF,3*CEP
3.15台液相,5台气相,ICP-MS、粒度仪、XRD、TGA、DSC等高端仪器。
工厂优势
1)2个API生产车间,16条常规API独立生产线,4个独立洁净区,200台(套)生产设备,反应体积50~5000L。
2)4条OEB-4独立生产线,1个独立洁净区,反应体积20~1000L。
3)1条特殊反应生产线,含6种国家重点监控危险反应的自控系统:氢化、氯化、磺化、重氮化、烷基化、氧化。
4)高温:250℃; 深冷:-100