Home / Analytical Testing / ICH Stability Storage Services

Release and Stability Testing

Protect shelf life and regulatory readiness with stability and release testing services designed for compliance, continuity, and dependable data across development and manufacturing programs.
Release and Stability Testing

ICH stability and storage services you can rely on

Robust stability programs are essential to understanding product performance, supporting regulatory submissions and protecting patient safety. Our ICH stability storage services are designed to generate reliable, defensible data while maintaining uninterrupted control of your samples.

We operate state-of-the-art stability laboratories equipped with mapped storage chambers and validated, continuous monitoring systems. Our experienced teams manage studies using compendial, client-supplied, vendor-supplied, or internally developed and validated methods. Our services support shelf-life determination, ongoing stability, and post approval commitments with confidence.

Built-in redundancies, including external backup power generators, help safeguard sample integrity, and business continuity throughout the duration of your program.

Our ICH stability storage services include:

  • Short- and long-term stability programs: Accelerated and real-time stability studies supporting research, development, and commercial products.
  • Photostability studies: Temperature-controlled chambers with calibrated UV and visible light sources, executed to client protocols, or protocols developed by our team.
  • Validated stability storage: Mapped chambers with continuous environmental monitoring and alarm systems to ensure consistent, compliant storage conditions.
  • Program setup and tracking: Sample reconciliation, protocol entry, and stability tracking to maintain control and visibility throughout each study.

Storage options and specialized services

Our facilities offer a broad range of standard and custom storage solutions designed to meet evolving regulatory and program needs, with the flexibility to adapt as your product progresses.

Storage Chambers

A wide range of ICH-compliant and custom storage conditions supported by validated continuous monitoring systems and external backup power generators to protect against interruptions.

Freeze–Thaw Cycling

Designed studies to evaluate the impact of temperature fluctuations during shipping or storage, with expert interpretation and support if results fall outside expectations.

Photostability

Controlled photostability chambers with calibrated light sources, executed to established protocols or protocols developed by our stability experts. These studies provide evidence to satisfy ICH Q1B standards.

Custom Storage Conditions

Tailored storage environments developed to accommodate unique product requirements, with new conditions introduced as needed to expand capabilities and support novel programs.

Secure Data Accessibility

PacePort is our secure client data access portal; a web-based data delivery system that allows you to access to methods, specifications, reports, and other information at any time, from any location. The materials available via PacePort are of sufficient quality to be used during audits.

Get in touch

Whether you’re shaping early plans or preparing to scale, our teams are here to help you move forward with clarity and confidence. Start the conversation and we’ll get back to you quickly.