Parenteral products are sterile drugs, solutions, emulsions and suspensions. Parenteral products are unique from any other type of pharmaceutical dosage form for the following reasons: All products must be sterile and free from pyrogenic (endotoxin) contamination.

Release and stability testing are a vital part of new drug development and is conducted throughout a product’s life cycle. These studies confirm that the quality, safety, and effectiveness of drug products are preserved all through the shelf life as an essential requirement. This presentation will provide a brief overview of the parenteral drug products release testing as well as the ICH guidelines for stability testing.