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
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.
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