Competitor Product Analysis

As generic companies ready CMC sections for their ANDA submission, they frequently need to know how their API impurity profile compares to that of the innovator’s product.  Impurities that have proven particularly difficult to remove may be common to both, in which case there is likely toxicological data in the innovator’s original submissions that qualify which impurities are acceptable, and at what level.

Case study: A client submitted to us samples of their API (see Client API) along with representative commercial samples from an innovator company (see Comparator Drug Product). There were seven impurities in the client’s API that crossed the ICH threshold, and because of the nature of the API  direct isolation and NMR analysis would not be applicable.  Insights into the chemical structure of the impurities was gained by LCMS and LCMS/MS analysis alone, and four of the impurities present in the client’s API were unequivocally confirmed to be present in the commercial product.