Stability testing

BRIEFLY EXPLAINED

Stability Testing Throughout the Entire Product Life Cycle

Product stability is a critical quality attribute. Only valid stability data can demonstrate that a pharmaceutical product, medical device, or cosmetic product continues to meet defined quality requirements throughout its shelf life. HHAC supports you in the planning, execution, and documentation of stability studies in accordance with applicable ICH guidelines. From exploratory studies during development and registration studies to ongoing stability programs, we support our clients throughout the entire product life cycle. Our qualified climatic chambers allow storage under controlled conditions and the performance of all required analytical testing in a GMP-compliant environment.

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THE PROCESS

Every order starts

with the determination of the required test samples and the creation of test plans. We then accompany you through the entire development and market phase (product life cycle). Regulatory stability tests, such as exploratory or confirmatory studies, are conducted under ICH conditions.

To verify the shelf life of all products on the market, we conduct on-going studies. Test samples are stored in qualified climate facilities equipped with alarm systems, where the required climate conditions are consistently controlled and recorded.

Photostability tests and stress tests under defined climatic conditions and exposure are also possible in our laboratory.

On request, we will also undertake the development and validation of specific methods for you. And of course you will find all relevant work steps – GMP-compliant – in our documentation!

What Is a Stability Study?

A stability study evaluates how the quality of a product changes over time under defined storage conditions. The following quality attributes are typically monitored:

  • Assay (active ingredient content)
  • Purity
  • Degradation products
  • Dissolution
  • Water content
  • Physical parameters
  • Microbiological parameters
  • Packaging integrity

The objective is to provide scientific evidence of shelf life and to establish appropriate storage conditions. Stability data form an essential basis for regulatory submissions, variation procedures, and ongoing post-marketing surveillance.

Our Stability Testing Services

HHAC offers a complete range of services related to stability studies from a single source.

Regulatory Stability Studies According to ICH

  • Long-term studies
  • Intermediate studies
  • Accelerated studies
  • Confirmatory studies
  • Exploratory studies

All studies are conducted in accordance with relevant ICH requirements and under controlled climatic conditions.

Testing of light-sensitive active ingredients and products in accordance with ICH Q1B.

In-Use Stability Studies

Assessment of product stability after opening or reconstitution.

Transportation and Temperature-Cycling Studies

Simulation of transport and storage conditions to evaluate their potential impact on product quality.

Stress Testing

Investigation of degradation behavior under defined stress conditions such as temperature, humidity, or light exposure.

Ongoing Stability Programs

Periodic monitoring of marketed products to confirm their approved shelf life.

From Study Design to Final Report

Our services include:

  • Determination of sample amounts
  • Preparation of study protocols
  • Definition of storage conditions
  • GMP-compliant storage
  • Timely retrieval of samples
  • Analytical testing
  • Trend analysis
  • Final reporting and documentation

Upon request, we also develop and validate product-specific analytical methods or transfer existing methods as part of a structured method transfer program.

Why HHAC?

More Than 30 Years of Experience in Pharmaceutical Analytics

Since 1992, HHAC has supported pharmaceutical companies with analytical challenges, method development, and stability testing. The laboratory has experience with more than 400 active pharmaceutical ingredients and excipients across a wide variety of dosage forms.

Your Benefits

  • GMP-compliant execution
  • Storage and analytical testing from a single source
  • Dedicated contacts and project support
  • Assistance with study protocols and sample planning
  • Flexible project management
  • Experience with pharmaceuticals, medical devices, and cosmetics
  • Extensive expertise in regulatory requirements

FAQs

The duration depends on the study objective. Accelerated studies can often be completed within a few months, whereas long-term studies typically run for 12, 24, or 36 months.

For pharmaceuticals, the ICH Q1 series is particularly relevant. These guidelines include requirements for long-term, intermediate, and accelerated stability studies, as well as photostability testing.

We conduct stability testing for active pharmaceutical ingredients, finished pharmaceutical products, medical devices, cosmetics, and other regulated products.

Standard controlled conditions include:

  • 25°C / 60% RH
  • 30°C / 65% RH
  • 30°C / 75% RH
  • 40°C / 75% RH
  • 5°C
  • -20°C

Additional storage conditions are available upon request.

Long-term studies simulate actual storage conditions over extended periods. Accelerated studies use elevated stress conditions to reveal potential product changes more rapidly.

Yes. HHAC supports clients with method development, validation, and optimization of analytical procedures for stability studies.

Ongoing stability studies provide continuous monitoring of marketed products and confirm the shelf life established during the regulatory approval process.

Yes. We assist with determining sample amounts, preparing study protocols, and selecting appropriate storage and testing conditions.

Contact

Do you have an inquiry that you would like to clarify with us?
Then please feel free to call us. For further inquiries you can also contact us by e-mail or use our contact form.

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