Comprehensive Stability Testing & Study Services
- Accelerated and real-time stability testing of pharmaceuticals and chemicals (ICH Q1R)
- All zone stability testing including walk-in stability chambers
- Accelerated stability study of medical devices and disposables (ASTM F1980)
- Real-time stability study of medical devices and disposables (FDA guidelines)
- Accelerated and real-time stability studies of IVD products (WHO guidelines)
- Transport simulation studies (ASTM D4169 & ISTA)
What is stability testing and why is it important?
Stability testing evaluates how product quality changes over time under environmental conditions to determine shelf life and storage requirements.
Do you perform both accelerated and real-time stability studies?
Yes, we conduct both accelerated and real-time studies as per ICH and other global regulatory guidelines.
Can you support medical devices and IVD stability studies?
Yes, we provide stability testing for medical devices and IVD products as per ASTM, FDA, and WHO guidelines.
Do you offer multi-zone stability testing?
Yes, we support all climatic zones with advanced stability chambers, including walk-in facilities.
What is transport simulation testing?
Transport simulation evaluates product integrity under shipping conditions using ASTM and ISTA standards.
Stability Assured. Reliable Outcomes.
Stability testing is essential to determine the shelf life, quality, and performance of pharmaceutical products, medical devices, and IVDs under various environmental conditions. At Accuprec, we provide comprehensive stability testing services aligned with global regulatory standards to support product development and market approvals.
Our capabilities include accelerated and real-time stability studies, multi-zone stability testing, and specialized studies for medical devices and IVD products. With advanced infrastructure including walk-in stability chambers and controlled environments, we ensure accurate and reproducible results.
We also conduct transport simulation studies to evaluate product integrity during distribution, helping organizations maintain product quality across the supply chain.
Our Approach to Accurate & Compliant Testing
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
