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Chemistry

14C GMP Synthesis & Analysis

The Manufacture of 14C labelled Materials for use in Clinical Trials

Interpretation of the regulatory landscape, including Good Manufacturing Practice (GMP), to meet 14C clinical trial requirements varies.

Having successfully manufactured more than one hundred  14C labelled APIs and IMPs in the last few years Pharmaron has enormous experience of appropriate interpretation to ensure the 14C material is approved by the regulatory bodies for use in the intended clinical trial. 

Pharmaron has invested in scientists and facilities to create a world class service for GMP synthesis of Active Pharmaceutical Ingredients (APIs or Drug Substances) and Investigational Medicinal Products (IMPs or Drug Products).

Drug Product (IMP) Formulation Options

Our GMP facility has been inspected for MIA (IMP) license and approved. The capability is designed to support small scale human studies and where required we can manufacture the Drug Product (IMP). IMPs supplied by Pharmaron Chemistry are for oral administration.

Types of formulation approved are:

  • Solution
  • Suspension
  • Solids for reconstitution (often referred to as a ‘Drug in Bottle’)
  • Hard shell capsules

These formulations can be supplied radiolabelled, stable labelled or unlabelled. We also routinely ship GMP APIs and IMPs to clinics worldwide.

Instrumentation

Our dedicated GMP compliant QC lab is equipped with qualified instrumentation comprising:

 Waters and Agilent Radio-HPLC systems

-purity (CP, RCP and EP)

 Varian NMR

-residual solvents and structural characterisation

 Waters Platform LC-MS

-for identification and specific activity

 Jasco Infra red

-structural characterisation

 Mettler Toledo Karl Fischer

-water contents

 Agilent Headspace GLC

-residual solvents

 Agilent

-dissolution and disintegration

 TA Instruments Differential Scanning Calorimeter

-polymorphs and melting point

 TA Instruments Thermogravimetric analyser

-thermal stability and composition

We can also work with our partners should additional analysis be required.

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