Hi,

Please share your thoughts on the following questions.

I developed a HPLC assay method which will be used as quality control method for a raw material. The claimed purity of this raw material is above 95% and the main impurity is its enantiomer. My method could separate these two compounds at baseline resolution. We decide to use chroma ratio to quantify the purity of the raw material.

My questions are:
1. For this type of method, what kind of qualification/validation are typically necesary?

2. In the case of stability study, is the forced degration study necessary?

3.I feel the need to study the sample stability in handling. So I am thinking of adding dilute acid (which is part of my mobile phase)/base, 10ppm H2O2 (to mimic the dissolved O2 in water)and inducing natural light to samples. Hopefullu the sample would be stable. Any comments on this study?

Your inputs is much appreciated!

Hi,

1.) Validation parameters are given in the ICH 2A and 2B guidelines (www.ich.org).
2.) This schould be a question to your registration office. The answer depends on nature of sample, the kind of thing you plan to do with it.... Nothing for the forum.
3.)Studying the sample stability is certainly a good thing to do. Maybe you should place your filled vials in a refridgerator for some time to see possible solubility issues. Again it depeds on your sample.

Alex