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Female lab technician in a white coat and blue gloves conducting precise pipetting test in a pharmaceutical laboratory at Synergy Health Utrecht.

Testing and release for pharma and life sciences

Lab test
Healthcare & Pharma

Stability testing and sample storage

We specialise in performing cGMP-compliant stability studies and securely storing pharmaceutical samples under strictly controlled conditions. Whether you're developing a new drug, going through a regulatory approval process, or conducting ongoing quality control, we provide high-quality laboratory services and reliable storage facilities. Our service is flexible, fully customized, and aligned with your production and quality assurance processes.

Why choose us?

  • Fully GMP-compliant and WHO prequalified

  • ICH-compliant storage and reporting

  • Fast turnaround and tailored project support

  • Secure, reliable long-term storage with full traceability

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Why stability testing is essential

Stability testing is a critical part of pharmaceutical development and quality assurance. It provides insight into the shelf life, safety, and efficacy of a product under defined environmental conditions.

We evaluate how factors like temperature, humidity, and light affect the integrity of pharmaceutical products. These results are vital for:

  • Determining the correct shelf life

  • Supporting regulatory submissions (EMA, FDA, etc.)

  • Backing clinical trials and product development

  • Product release and market access

  • Quality control during transport and storage

All studies are conducted in accordance with ICH guidelines (International Council for Harmonisation)

We offer a wide range of stability testing services, including:

  • Initial stability studies for new pharmaceutical products

  • Ongoing studies to monitor marketed products

  • In-use studies to assess stability after product opening

  • Photostability studies to evaluate light sensitivity

Each study begins with a detailed, tailored protocol. This includes information about the samples, test conditions, time points, and analytical methods. Our trained analysts perform all testing using state-of-the-art equipment, and results are statistically evaluated before being reported, allowing for early detection of trends or degradation.

Controlled Storage According to ICH Conditions

Accurate and compliant storage is essential for any reliable stability study. Our temperature- and humidity-controlled chambers are qualified for all standard ICH storage conditions, including:

  • –20°C ± 5°C

  • 5°C ± 3°C

  • 25°C ± 2°C / 60% RH ± 5%

  • 30°C ± 2°C / 65% RH ± 5%

  • 40°C ± 2°C / 75% RH ± 5%

All storage units are monitored 24/7. If any parameter goes out of specification, our alarm system is triggered immediately, ensuring the full integrity of your samples. Non-standard conditions or special requirements? We are happy to discuss customized setups.

Our test methods

  • Active Pharmaceutical Ingredient

    Compendial method BP/EP/JP/USP – Initial Stability Study – Ongoing Stability Study

  • Excipients

    Compendial method BP/EP/JP/USP – Initial Stability Study – Ongoing Stability Study

  • Finished formulations

    Compendial method BP/USP/ Customer specific method – Initial Stability Study – Ongoing Stability Study – In-Use Stability Study

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Leading companies in this service

Normec Synergy Health

Nieuwegein Netherlands

Lab test
Healthcare & Pharma
Normec Synergy Health, a leading Contract Research Organization (CRO) in the Netherlands, brings over 60 years of expertise in pharmaceutical analysis. Our accredited laboratories and skilled staff are dedicated to delivering the highest quality and flexibility to clients across the global life sciences sector, including pharmaceutical, medical device, nutraceutical, and cosmetics companies.
Learn more

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