With world class facilities and over 50 years experience in radiosynthesis, we offer unparalleled resources for the custom synthesis of carbon-14 labeled compounds. We offer the following quality services:
Premium
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Certified to ISO9001:2000 by Lloyds Register of Quality Assurance
Good Manufacturing Practice (GMP)
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Accredited by the Medicines and Healthcare Products Regulatory Agency (MHRA). Certificate No: UK PI 221/108585
GMP guidelines
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Similar to accredited GMP but with the flexibility to define your exact requirements
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Provides more control to meet internal QA requirements for human studies
Service offering details
Types of preparation - most organic compounds including:
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Aromatics
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Heterocycles
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Polymers
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Peptides and proteins
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Fermentations
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Volatile compounds
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Chiral compounds
QC equipment and techniques
Standard Quality Control specifications
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Mass spectrometry for structural analysis and for determining specific activity
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TLC and HPLC for determining radiochemical purity
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1H NMR for structural information
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Product specification sheet and analytical scans are provided for each preparation
We have a dedicated team of radiochemists regularly manufacturing bulk quantities of basic carbon-14 intermediates. These compounds are used in the preparation of radiolabeled final products and are formulated in the most convenient form for the customer. A full list of available intermediates can be viewed in the following tables:
The GE Healthcare Amersham Radioloabeling Service delivers high quality organic compounds and biomolecules labeled with carbon-14 and tritium. For the preparation of carbon-14 labeled compounds, a newly commissioned facility has been approved by the Medicines and Healthcare Products Regulatory Agency to manufacture 14C-labeled compounds to Good Manufacturing Practice (GMP) standard.
Designed to meet the increasing needs of pharmaceutical researchers to build GMP into clinical trials from the earliest stages of drug development, the GMP-accredited 14C-labeling service allows pharmaceutical R&D to incorporate GMP into clinical trials. It also provides the reassurance of complete documented traceability from the outset.
• Extends existing range of ISO9001-compliant services to the pharmaceutical industry
• Satisfies increasing regulatory demands associated with pharmaceutical development
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