Headspace oxygen levels in pharmaceutical products are critical to ensure product stability and safety. Regulatory guidelines provide specific limits and recommendations for controlling headspace oxygen to maintain product efficacy and quality. Here’s an overview based on industry standards and pharmacopeial guidelines: Importance of Controlling Headspace Oxygen: 1. Product Stability: Oxygen can degrade active pharmaceutical…
In ANDA submissions, the FDA typically requires stability data for at least 180 days. This data is a part of the chemistry, manufacturing, and controls (CMC) section of the application. The purpose of stability studies is to demonstrate the drug product’s stability over time, ensuring its quality and efficacy throughout its shelf life. This…
1. Accelerated stability studies These studies involve subjecting the pharmaceutical product to higher temperatures and humidity levels than normal storage conditions to determine its stability over a shorter period of time. 2. Long-term stability studies These studies involve storing the pharmaceutical product under normal storage conditions for an extended period of time, typically up…
