Moravek，同位素试剂化合物供应商，公司介绍，品牌代理
自1975年以来，Moravek公司一直致力于通过研发提供高质量的科研产品来促进人类健康，并获得加州卫生服务部(DHS)食品和药物部门的许可，用于临床试验的活性药物成分(API)的制备和C14标记化合物。我们定制的放射合成、纯化、稀释、释放、放射化学稳定性测试和QA评审文件化过程始终符合cGMP要求并保证质量。Moravek提供的所有100多个cGMP 14C标记原料药都适合在美国和世界各地的早期临床试验中使用。Moravek公司拥有最大的放射化学集团之一和最先进的设施和设备，拥有专业知识和能力，为您的临床试验及时提供符合发布规范的定制放射标记api。除了cGMP放射合成，Moravek提供的解决方案还包括碳-14和氚标记化合物的非GMP放射合成，广泛的GLP分析服务和超过2500个高纯非GMP标记化合物的研究目录。
Moravek has been committed to the advancement of human health through provision of quality products for research since 1975 and is licensed by the California Department of Health Services (DHS) Food and Drug Branch for the preparation and C-14 labeling of active pharmaceutical ingredients (API) for clinical trials.
Our custom radiosynthesis, purification, dilution, release, radiochemical stability testing, and QA reviewed documentation process consistently achieves cGMP compliance and assurance of quality.
All of the over 100 cGMP 14C labeled APIs provided by Moravek were suitable for use in early phase clinical trials in the US and around the world.
With one of the largest radiochemistry groups and state-of-the-art facilities and equipment, Moravek has the expertise and capacity to supply custom radiolabeled APIs that meet release specifications and are on time for your clinical trial.
In addition to cGMP radiosynthesis, solutions offered by Moravek include non-GMP radiosynthesis of carbon-14 and tritium labeled compounds, extensive GLP analytical services and a catalog of over 2,500 highly pure non-GMP radiolabeled compounds for research.
Solutions offered by Moravek include
• cGMP manufacture of 14C labeled APIs for clinical trials
• cGMP manufacture of 3H labeled, stable-labeled and non-labeled APIs for clinical trials
• Quality critical analytical services include UPLC, HPLC, MS, LC-MS, ICP-MS, Headspace GC, XRPD, and NMR
• Method transfer and method feasibility check under GLP or cGMP
• GLP custom synthesis of 14C, 3H, stable-labeled, and non-labeled compounds
• Agilent OpenLab Enterprise Content Management (ECM) system for 21 CFR Part 11 compliance
• Stability studies and storage utilize a 21 CFR Part 11 compliant Rees Scientific Environmental Monitoring System (EMS)
• Non-GLP grade custom synthesis of 14C, 3H, stable-labeled, and non-labeled compounds
• Purification by HPLC, flash and lobar chromatography, as well as preparative gas chromatography
• Catalog of over 2,500 exceptionally high quality non-GLP grade labeled compounds
• All operations are supported by 500 kW of Cummins PowerCommand cloud monitored backup power
• Comprehensive logistics services include storage, dispensing, shipping, chain of custody and temperature tracking
产品目录
Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-A
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-B
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-C
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-D
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-E
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-F
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-G
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-H
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-I
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-JKL
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-MN
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-OPQR
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Moravek，同位素试剂化合物供应商，公司介绍，品牌代理，产品目录-STUVWXYZ
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