Stability Testing for Medical Cannabis: Ensuring Shelf Life and Compliance

The medical cannabis industry is rapidly expanding, with increasing regulatory scrutiny ensuring that products meet quality, safety, and efficacy standards. A key component of product quality assurance is stability testing, which determines a product’s shelf life and ensures compliance with industry regulations.

For manufacturers, ensuring batch-to-batch consistency is crucial—not just for regulatory approval but also to maintain consumer confidence in product effectiveness.

What Do Manufacturers Need to Consider?

To successfully bring a medicinal cannabis product to market, manufacturers must:

• Demonstrate product stability over time
• Meet ICH & GMP regulatory standards
• Ensure quality and potency remain consistent
• Use ICH-compliant stability testing to support regulatory submissions

In this blog, we explore why stability testing is essential, how it works, and how Broughton’s expertise can support manufacturers in achieving compliance and market success.

What Is Stability Testing and Why Is It Important?

Stability testing for medical cannabis is a scientific process that evaluates how a product degrades over time under different environmental conditions such as temperature, humidity, and light. This helps manufacturers determine:

• Shelf Life – How long the product remains potent, safe, and effective
• Regulatory Compliance – Ensures products meet ICH guidelines, GMP standards, and other market regulations
• Consistency & Consumer Trust – Delivers a reliable and stable product for patients

Without stability testing, manufacturers risk product degradation, compliance failures, and market delays.

How Does Stability Testing Work?

Stability Storage & Testing Conditions

Stability testing involves placing samples into environmentally controlled chambers to monitor how the product’s quality changes over time.

At Broughton, our ICH-compliant medicinal cannabis testing follows a structured process to evaluate product performance over extended periods.

Key Stability Conditions (Industry-Standard Testing Environments):

• 25°C / 60% RH – Real-time stability (Standard storage conditions)
• 30°C / 65% RH – Intermediate stability (Mild stress testing)
• 40°C / 75% RH – Accelerated stability (Forced degradation studies)

Each condition simulates real-world scenarios to help predict how the product will behave throughout its shelf life.

Broughton ensures real-time tracking of stability data using our Laboratory Information System (LIMS), LabHQ, enabling manufacturers to:

• Track stability trends over time
• Receive early warnings of potential quality issues
• Generate a Certificate of Analysis for regulatory submission

By exposing medicinal cannabis products to controlled temperature and humidity conditions, we identify potential changes in:

• Potency (cannabinoid degradation)
• Microbial contamination
• Physical properties (colour, texture, odour)

This data is critical for regulatory approvals and supports informed decision-making throughout the product’s lifecycle.

Why Stability Testing Is Critical for Regulatory Compliance

ICH & GMP Guidelines for Stability Studies

The global regulatory landscape for medicinal cannabis is evolving, and stability testing is a non-negotiable requirement for market entry.

The International Council for Harmonisation (ICH) sets global stability testing standards, which are recognised by:

• The UK & EU
• The United States (FDA)
• Other international markets

Broughton also ensures that stability testing aligns with Good Manufacturing Practice (GMP), a fundamental requirement for pharmaceutical-quality medicinal cannabis products.

GMP compliance ensures:

• Strict quality control measures
• Consistency across production batches
• Confidence in meeting safety, purity, and potency standards

Without ICH-compliant medicinal cannabis testing and GMP adherence, manufacturers risk:

• Regulatory rejection – Insufficient evidence to support shelf-life claims
• Non-compliance with storage guidelines – Failure to meet ICH and GMP conditions
• Product inconsistency – Variability in THC/CBD levels affecting therapeutic effects

With Broughton’s ICH-compliant stability chambers and GMP-ready facilities, manufacturers can confidently submit stability data for regulatory approval, helping to accelerate market access.

Common Stability Testing Challenges (And How to Overcome Them)

Despite its importance, stability testing for medicinal cannabis presents unique challenges:

• Complex Product Formulations – Medicinal cannabis products contain multiple active compounds (e.g., cannabinoids, terpenes), each degrading at different rates.
  Solution: Customised stability protocols tailored to specific formulations.
• Regulatory Variability – Stability testing requirements differ across global markets, creating compliance hurdles.
  Solution: Partner with a provider experienced in global cannabis regulations.
• Cost & Time Constraints – Long-term stability testing can be resource-intensive.
  Solution: Accelerated stability testing helps predict long-term stability faster.

By proactively addressing these challenges, Broughton helps manufacturers navigate the complexity of stability testing efficiently and cost-effectively.

Why Choose Broughton for Stability Testing?

With deep expertise in ICH-compliant cannabis testing, Broughton offers end-to-end support to help manufacturers bring safe, compliant, and high-quality products to market.

Key Benefits of Broughton’s Stability Testing Services

• ICH-Compliant Stability Chambers – State-of-the-art storage for stability studies
• GMP-Ready Testing Facilities – Ensuring high-quality, pharmaceutical-grade standards
• Home Office Schedule 1 Controlled Drugs Licence – Authorised to possess and supply cannabis flower., oils and finished products.  
• Real-Time Digital Monitoring – Full transparency via our LIMS, LabHQ, tracking & reporting
• On-Site Stability Chambers – Immediate issue resolution, minimising delays & costs
• Regulatory Expertise – Extensive experience in UK medical cannabis compliance

Take the Next Step – Book Your Stability Study

Ensure your medicinal cannabis product meets stability, GMP, and compliance standards with Broughton’s expert-led testing services.

Get in touch with our team today to schedule your stability study.