7. GLOSSARY

Degradation ? Product : An impurity resulting from a chemical change in the drug substance brought about during manufacture and/or storage of the new drug product by the effect of , for example , light , temperature , pH , water .Or by reaction with an excipient and/or the immediate containe closure system .Specified ? Degradation ? Product : A degradation product that is individually listed and limited with a specific acceptance criterion in the new drug product specification .