There are numerous reasons why pharmaceutical companies at some point turn to an outsourcing solution provider. It can be a matter of streamlining operations, cutting time to market or reducing costs. Last but not least, outsourcing laboratory services is a quick and efficient way to gain access to special capabilities and expert knowledge.
Analytical service is no exception.
Now, let’s look at some of the issues and challenges that are significant for pharmaceutical analytical chemistry.
Characterization of a new active pharmaceutical ingredient, API, requires a battery of methods and techniques. To analyze how the very same API works, responds or degrades in a formulation, normally calls for a totally different toolbox.
Running an analysis on API alone is a quite straightforward operation because the sample is very pure. After formulation, on the other hand, the API must be extracted before it can be analyzed. This can sometimes be a rather tricky and time consuming operation, highly dependent on dosage form.
The chemical stability must be studied to determine, for instance, the expected shelf-life of the drug. To do so, samples must be taken, in which all of the API as well as all possible degradation products are accounted for with high accuracy.
All excipients have an impact on the API. A combination of two or more excipients can produce yet another response that will affect the stability or efficacy of the medication. Even though many APIs are similar and have common chemical traits, each and everyone require its own analysis. Likewise, any change in the mix of excipients may introduce new analytical challenges.
The fine art of pharmaceutical analysis is not so much a question of knowing what kind or how much of an API that goes into a formulation, but rather making sure that all of it always can be traced at any time.