Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
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Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
Container Closure Requirements: Preparing for USP
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the...
Release and Stability Testing Requirements for Parenteral Drug Products
Parenteral products, which include sterile drugs, solutions, emulsions, and suspensions, are distinct from other pharmaceutical dosage forms...
ICH Stability Testing and Method Development
Stability testing is an essential component of product development, conducted throughout the entire lifecycle of a biotherapeutic...
