When setting up a stability programme for a pharmaceutical substance or product, analytical methods are selected to allow appropriate testing at the required time-points. A number of different types of methods may be selected but the quantitative measure of the active pharmaceutical ingredient (API) and its degradation products is probably the most important.
Since these methods are being used to interpret the effects of the stability study then it is self evident that they need to be stability indicating but how can you be sure that this is the case? The challenge is to demonstrate that each method is, in the words of ICH Q2(R1), "suitable for its intended use".
To demonstrate suitability, and therefore show that your method is stability indicating, you will need to be able to quantify the API and its degradation products so that you can monitor the expected decrease in the amount of the API and the corresponding increase in the amount of degradation products. Therefore, samples of the degradation products will be necessary to show the method is capable. These are usually sourced by applying stress to the samples in a forced degradation study. Although the principle is straightforward, this type of investigation can be very problematic and requires a thorough understanding of the chemical properties of the API and predicted degradation products.
When carrying out an audit which involves stability testing, I will often ask the question "Is this analytical method stability indicating?" What I expect to see is a section in the validation report which details the evidence that demonstrates that the method is stability indicating.
Since the analysis of an API and its degradation products most often requires the use of HPLC, Mourne Training Services has created a training course which focuses on how to develop stability indicating HPLC methods. Strategies for generation of suitable degradation products via forced degradation is combined with a thorough step by step guide to HPLC method development.
How to Develop Stability Indicating HPLC Methods
In London (Jurys Inn Heathrow) on the 11th & 12th November and in Berlin (GLS Campus Berlin) on the 9th & 10th December 2013
Early booking rate: London - £850 + VAT; Berlin - €1050 + VAT
Late booking rate: London - £950 + VAT; Berlin - €1175 + VAT