We have a product of storage condition below 25 C. We would like to submit the data, but the stability study failed for an impurities test at both accelerated (40C) and intermediate (30C). Long term stability at 25C passed for the first batch through shelf life (24M) and the second batch has reached 12M and still conforms. We also completed a stability study for the branded product and the impurities also failed at both accelerated and intermediate studies–intermediate failed at 12M compared to 9M for our product. Can we submit this file with these issues? What is an acceptable justification we could include in the filing? In other words, what does one do when both accelerated and intermediate stability fails?
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