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Stability Studies - Lab Services - QbD Group

Stability Studies

Protect the integrity and shelf-life of your products

At QbD Group, we understand that the stability and shelf-life of your product are critical to its success. With our comprehensive expertise and state-of-the-art facilities, we ensure your products meet the highest quality standards through rigorous stability studies. Let us help you safeguard your product’s reliability and market success.

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What are stability studies?

Stability studies are scientific investigations conducted to determine how the quality of a product varies with time under the influence of environmental factors such as temperature, humidity, light, and pH. These studies assess the product’s physical, chemical, microbiological, and functional properties over its lifecycle.

Key aspects include:

  • ICH stability testing: Long-term, intermediate, and accelerated studies.

  • Stress testing: Examining product responses to extreme conditions like oxidation, temperature fluctuations, and light exposure.

  • In-use stability testing: Evaluating product stability during typical usage conditions.

  • Temperature cycle tests: Freeze-thaw and transportation simulations to ensure resilience during shipping.

  • Validation of stability-indicating methods: Developing methods to track product degradation accurately.

Discover why stability studies are essential

Stability Studies - Lab Services - QbD Group (1)

Why are stability studies essential?

  • Regulatory compliance: Stability testing ensures your product meets the strict requirements of health authorities, preventing delays and ensuring market approval.

  • Shelf-life determination: Helps establish appropriate storage conditions and expiry dates to maintain product efficacy and safety.

  • Product quality assurance: Confirms that your product remains stable under specified environmental conditions, safeguarding patient safety.

  • Risk mitigation: Identifies and addresses potential stability issues during development, reducing the risk of costly recalls or compliance failures.

  • Market confidence: Assure customers and stakeholders of your product’s quality.

  • Support for global markets: Enables compliance with international guidelines like ICH, facilitating worldwide distribution.

  • Cost efficiency: Identify potential issues early to avoid costly recalls or rework.

  • Data-driven decision making: Optimize formulation, packaging, and storage conditions based on stability data.

 

Discover how we can help you

How can we help?

At QbD Group, we offer a complete suite of stability study services tailored to your needs. Our ICH-compliant stability storage facilities are equipped with advanced technology for 24/7 monitoring, access control, and alarm systems to ensure the integrity of your samples.

ICH stability testing

ICH stability testing

Conduct long-term, intermediate, and accelerated testing following ICH guidelines. 

Stress testing

Stress testing

Assess stability under challenging conditions, including light, pH, humidity, and oxidation.

In-use stability testing

In-use stability testing

Evaluate stability during typical use scenarios.

Temperature cycle tests

Temperature cycle tests

Simulate freeze-thaw cycles and transportation stress.

Stability-indicating method development & validation

Stability-indicating method development & validation

Ensure accurate tracking of product degradation.

Comprehensive study management

Comprehensive study management

From protocol development to reporting, we provide end-to-end support.

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Why QbD Group?

With QbD Group, you gain:

  • Deep expertise: Decades of experience in stability testing across various industries.

  • State-of-the-art facilities: Fully secured, ICH-compliant stability storage.

  • Tailored solutions: Customized testing strategies aligned with your product’s requirements.

  • Regulatory support: In-depth understanding of global regulatory standards.

  • End-to-end services: From study design to execution, we manage every step.

Our dedicated team combines technical know-how with a commitment to delivering reliable, actionable insights for your stability studies.

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Ready to ensure the stability of your product?

Partner with QbD Group for comprehensive stability studies that meet the highest quality standards. Contact us today to discuss your project and discover how we can support your product’s success.

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