Methods
Stability Storage & Testing

Stability Storage & Testing

ICH-guided stability storage and testing designed to evaluate product integrity, shelf life, and long-term performance.

About Stability Storage & Testing

PLS Analytical delivers stability storage and testing services through controlled laboratory systems, regulatory-aligned study designs, and quality-focused monitoring systems to support pharmaceutical and healthcare products throughout development and commercialization. Our stability programs generate reliable, traceable, and submission-ready data to support shelf-life determination, storage recommendations, packaging evaluation, and regulatory requirements.

Testing is conducted under controlled ICH storage conditions to evaluate how environmental factors such as temperature and humidity may impact product quality, potency, stability, and packaging performance over time.

Why it matters?

Stability testing plays a critical role in determining how pharmaceutical products perform throughout their intended shelf life under different environmental and storage conditions. By generating long-term, intermediate, and accelerated stability data under ICH-guided conditions, manufacturers can establish appropriate storage recommendations, evaluate degradation behavior, support regulatory submissions, and maintain product quality throughout the lifecycle.

Testing Types

Scientific testing services designed to support reliable and compliant products

25°C / 60% RH (CRT)

Controlled room temperature (CRT) stability studies conducted under long-term ICH storage conditions to evaluate product quality and shelf-life performance over time.

30°C / 65% RH (Intermediate)

Intermediate stability studies performed to assess product behavior under moderately elevated temperature and humidity conditions.

40°C / 75% RH (Accelerated)

Accelerated stability studies designed to evaluate the impact of elevated stress conditions on product stability, degradation behavior, and packaging performance.

Key Advantages

Controlled stability programs supporting reliable shelf-life and regulatory data

At PLS Analytical, stability studies are managed through scientifically controlled storage environments, ICH-aligned conditions, and quality-focused monitoring systems designed to generate reliable and traceable stability data.

Controlled ICH stability programs

Stability studies conducted under controlled ICH storage conditions to support regulatory requirements, submissions, audits, and long-term product quality evaluation.