English to Russian Medical Medical: Pharmaceuticals response document

An authority writes to a pharmaceutical company:

Thus, according to the ICH Q3B and GF XIV guidelines, the maximum daily dose of the drug is from 10 mg to 2.0 g (for this drug, 800 mg) control of unidentified impurities must be at the level of "not more than 0.2 %", and impurities with a content of more than 0.2 % must be identified and, if necessary, qualified (their safety must be confirmed). In this connection: provide data on the study of the stability of the drug, indicating the actual results for the content of identified and unidentified impurities (the data provided shows the actual values for one maximum impurity);