Moravek 产品代理

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Moravek 产品代理

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审查的文件过程一致达到cGMP的符合性和质量保证。

所有由Moravek提供的超过250个cGMP 14C标记的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拥有最大的放射化学团队和最先进的设施和设备,有专业知识和能力提供定制的放射标记api,满足发布规范,并及时为您的临床试验。
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cGMP [14C] API Radiolabeling

Radiolabeling

Organic Synthesis Chemistry Services

QC & Analytical Support



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.

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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 250 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.