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Release & Stability Testing Requirements for Parenteral Drug Products

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.

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