Skip to content
  • Clinical Studies
  • Pharma Tips
  • Pharma GMP
  • Pharma SOP
  • Pharma Books
  • Schedule M
StabilityStudies.in

StabilityStudies.in

Pharma Stability: Insights, Guidelines, and Expertise

Tag: regulatory response new impurities

Impact of New Impurity Formation in Long-Term Stability Studies

Posted on By

Impact of New Impurity Formation in Long-Term Stability Studies Managing the Impact of New Impurity Formation in Long-Term Stability Studies Long-term stability studies are critical to understanding how a pharmaceutical product degrades over time under recommended storage conditions. Occasionally, these studies reveal the formation of new impurities not observed during accelerated or initial development testing….

Read More “Impact of New Impurity Formation in Long-Term Stability Studies” »

Intermediate and Long-Term Stability Testing, Stability Testing Types

Quick Guide

  • Stability Tutorials
  • Stability Testing Types
    • Types of Stability Studies
    • Real-Time and Accelerated Stability Studies
    • Intermediate and Long-Term Stability Testing
    • Freeze-Thaw and Thermal Cycling Studies
    • Photostability and Oxidative Stability Studies
    • Stability Testing for Biopharmaceuticals
  • Stability Studies SOP
  • ‘How to’ – Stability Studies
  • Regulatory Guidelines
  • Shelf Life and Expiry Dating
  • Stability Documentation
  • Stability Studies – API
  • Stability Studies Blog
  • Stability Studies FAQ
  • Packaging – Containers – Closers
Widget Image
  • Fully Validate Stability-Indicating Methods Before Use in Studies

    Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API)… Read more

Copyright © 2025 StabilityStudies.in.

Powered by PressBook WordPress theme