- State-of-the-art Analytical Services facility in the USA
- Physical and Chemical Characterisation
- Method Development and Validation
- API & Drug Product Testing
- Stability Testing
- Impurity Identification and Structure Elucidation Services
- Bioanalytical Services
Impurity Identification and Structure Elucidation Services
Foreign material in your product?
Unknown chromatographic peaks?
Then let Almac assist.
Our state of the art laboratories and highly experienced scientific staff are on hand and equipped to identify and fully characterise: reference standards, API’s, impurities, powders, tablets, capsules, creams and liquids.
What we do?
Our dedicated cGMP MS and NMR facility routinely perform the identification of degradation products seen during stability testing, impurities during API and drug product testing, and metabolites during bioanalysis.
Structural elucidation and chemical characterisation of compounds using MS, NMR and IR are carried out on a daily basis.
In some cases, impurities can be examined using an infra-red micro-spectrometer combining chemical analysis with conventional light microscopy. Detailed library searches can be undertaken and comparisons to spectral data of fibres, contaminants, packaging materials, and other substances can be made. High through-put NMR services are available for early phase development. We also offer NMR support to help you interpret your spectra and give advice on experiments and strucural issues.
Process chemistry knowledge to help determine the likely source of impurities, as well as provide process optimisation skills to eliminate them. We also have the instrumentation and synthetic capabilities to isolate or manufacture the impurities.
Increased knowledge of your impurities will help with the method development and validation of your analytical methods.
Flexible, professional, dedicated staff assigned to specific projects; experts in their technical field and experienced in the regulatory requirements of chemical analysis and scientific report writing.
Our client portfolio includes large, small and virtual pharmaceutical companies who have benefited from our attention to detail and dedication in getting results to them right on time, every time.