HPLC method development for analysis of a multi-component drug product
Developing a high performance liquid chromatography (HPLC) method for the analysis of compounds is a task that usually requires much expertise and is also extremely time-consuming. This becomes even more complex if the sample is a mixture of multiple components. This poster reports development and validation of a stability-indicating HPLC method for a drug product with two API’s and 21 known impurities. The initial development work was approached by employing the quality by design principles outlined in the ICH guidelines Q8 and Q9. Based on the material, process and product attributes the method has to measure, the performance requirement for the HPLC method and optimum chromatographic conditions were identified. The optimum conditions are examined and further fine tuned during the development stage.
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Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.