• Q1A(R2): Stability Testing of New Drug Substances and Products

• Q1B: Photostability Testing

• Q1C: Stability Testing for New Dosage Forms

• Q1D: Bracketing and Matrixing Designs

• Q1E: Evaluation of Stability Data

• Q1F: Stability Data Package for Global Submission

These guidelines ensure compliance with global regulatory standards, providing essential data for shelf life determination, storage conditions, and regulatory submissions. At CRAMSN, we optimize drug product stability through accelerated, long-term, and intermediate testing, as well as in-use stability for multi-dose formulations, ensuring quality and consistency across the product lifecycle.

Our comprehensive stability studies are designed to assess the stability profile of drug substances and products, helping establish retest periods, shelf life, and appropriate storage conditions for global regulatory submissions.

Key stability studies at CRAMSN include

Accelerated Stability Testing: Simulating long-term degradation under elevated temperature and humidity (40°C ± 2°C / 75% RH ± 5%) to predict shelf-life in a compressed timeframe.

Long-Term Stability Testing: Real-time studies under controlled conditions (25°C ± 2°C / 60% RH ± 5%) to assess the product’s integrity throughout its intended shelf life.

Intermediate Stability Testing: Testing under conditions (30°C ± 2°C / 65% RH ± 5%) to evaluate performance in borderline storage environments.

In-Use Stability Studies: Assessing multi-dose formulations or reconstituted products for microbiological integrity, potency, and stability over the usage period.

Photostability Testing: Conducting ICH Q1B-compliant tests under controlled lighting to evaluate the effect of light exposure on drug substances and products.

We use validated software platforms for real-time data monitoring and trending to ensure regulatory-compliant data integrity (ALCOA+) for submission-ready reports. Our stability chambers are qualified to monitor various ICH-specified conditions such as 25°C / 60% RH (long-term), 30°C / 65% RH (intermediate), and 40°C / 75% RH (accelerated), as well as refrigerated (-5°C) and frozen conditions (-20°C).

With oFur detailed data analysis, we provide regulatory-ready stability reports in CTD format to support NDA/ANDA/MAA submissions and shelf-life claims, ensuring compliance with global regulatory requirements (e.g., USFDA, EMA, PMDA).