ICH Quality Gudelines

Q3B (R2) Impurities in New Drug Products

1. Introduction

Consult Q3A and Q3C
Concepts mostly similar as those in Q3A.

7. Glossary

Deg Product: An impurity resulting from a chemical change in the DS during manufacture and/or storage of the DP by light, temperature, pH, water, excipient and/or the container.
Deg Profile: A description of deg pdt.
Identified Deg Pdt: known structure.
Unidentified Deg Pdt: structure unknown, defined solely by qualitative analytical properties (RT).
Specified Deg Pdt: see specified impurity.
Unspecified Deg Pdt: see unspecified impurity.