Pharmaceutical Stability Testing and Storage

Pharmaceutical stability testing from SGS – help confirm product stability and identify possible changes to the potency, function and safety of pharmaceutical drug substances, intermediates and products following storage under controlled conditions.

Pharmaceutical stability testing demonstrates that materials and products in their containers are:

Suitable for use in production
Remain usable, safe, potent and efficacious for patients throughout their lifecycles

We provide formal stability testing for pharmaceuticals, following international guidelines (ICH Q1A to Q1F) as well as any additional country specific guidelines required for product registration for your intended marketing plan.

Our life cycle investigations start with product development and include:

Forced degradation according to ICH Q1A(R2), and photostability (ICH Q1B), to identify the likely degradation of products. This helps to determine the intrinsic stability of the molecule, establish degradation pathways, and validate the stability indicating procedures used
Excipient compatibility studies – data generated identifies the stable formulation, and supports choice of materials and packaging
Studies under controlled temperature and humidity to help demonstrate that developed methods are stability indicating
Accelerated or custom programs, through development, to assess the product and material performance of drug substances, intermediates through synthesis or production, and drug products, to guarantee quality and safety during the material/product life cycle

All our stability programs are run under controlled and monitored conditions 24/7.

Why choose pharmaceutical stability testing from SGS?

We can help you:

Design stability studies that evaluate all aspects of your drug substance or drug product’s life cycle
Simulate the conditions under which your drug substance or drug product will be subjected – from manufacturing to final application
Determine how the quality of your drug substance or drug product varies under the influence of temperature, humidity and light
Define the appropriate conditions and timeframe, accounting for the fact that most chemical reactions follow logarithmic and not linear functions
Define retest periods for drug substances
Determine the shelf life of your drug products and recommended storage conditions
Demonstrate that your drug product complies with acceptance criteria throughout its life cycle

Medicine in Shelves in Commissioning Machine in Pharmacy

Trusted pharmaceutical stability testing from a world leading life sciences provider

As a world leading provider of services to the life sciences sector, we provide the largest network of contract testing laboratories. With 29 facilities across 15 countries, we offer clinical research services, analytical development, biologics characterization, utilities qualification, biosafety and quality control testing for leading pharmaceuticals across the world. Our dedicated laboratories are fully cGMP qualified and FDA/MHRA registered and inspected.

To find out more about our pharmaceutical stability testing services, contact us today.