Conclusions regarding the ICH guideline

The lists are not exhaustive and other solvents can be used and added later to the lists. Recommended limits of class 1 and class 2 solvents or classification of solvents may change as new safety data become available. 

Nevertheless this Guideline is of great interest for those involved in the pharmaceutical development in order to prepare successfully a pharmaceutical dossier acceptable everywhere in the world. 

Those who have worked for many years in pharmaceuticals will have observed continuous progress in standards of Quality and Control in manufacturing. 

Solvents including water are still used in almost every step of the elaboration of a drug product. Their residues could be detrimental for the processability and stability of the pharmaceutical products and the safety of patients. At die end of this millennium it can be said that the testing and control of RS has been thoroughly assessed and is based on robust and sensitive techniques, for which the limitations are known, resulting in a sound strategy accepted almost everywhere in the world. 

1 Societa Italiana di Scienze Farmaceutiche, Cronache Farmaceutiche, 6, 227-229 (1980). 

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