At every state of your drug development program, Exova supports you with advanced pharmaceutical stability storage and testing services.

The conditions under which drug products are manufactured, transported and stored can influence their efficacy. Stability studies help to estimate the impact of transportation and storage on drug and medical device performance by stressing materials under exaggerated environmental conditions. Appropriate temperature, humidity, and light guarantee that drugs are delivered to patients without loss of therapeutic properties.

Stability studies enable identification of any potential chemical or physical changes that could potentially impact product safety and quality. The data obtained from these studies allow optimal transportation and storage conditions to be established and verify product shelf-life.

Exova’s stability storage and testing services include:

  • Stability protocol preparation, coordination, and execution by a highly experienced team familiar with a range of dosage forms, devices, and delivery systems
  • Development and validation of stability-indicating assays, including forced degradation studies
  • Accelerated test programs in support of prototype evaluation and process development
  • Complete chemical and physical analytical testing capabilities supported by senior scientific staff for timely investigation and resolution of out of specification results.

Our stability programs are strictly controlled using 21CFR, part 11 compliant project management software. With chambers monitored, fully validated and alarmed, whether your project is a small one-off study or a major program we can provide you with a low-risk, high-quality stability study.

International Conference on Harmonization guidelines (ICH) conditions offered include:

  • -20°C (± 5°C)
  • 5°C (± 3°C)
  • 25°C/40%RH, 25°C/ 60%RH (± 2°C/±5%RH)
  • 30°C/35%RH, 30°C/ 65% RH, 30°C/75%RH (± 2°C/±5%RH)
  • 40°C/ 75%RH (± 2°C/±5%RH)
  • Photostability

Exova’s stability team provides high-quality data in support of all stages of drug and device development, from early research through full finished product studies that adhere to ICH guidelines.

  • Contact Us

    Whatever your query, we'll pass it on to our experts and respond within a very short space of time.
    More details
Pharmaceutical testing facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111

Fax: +1 905 823 1446

Email: americas@exova.com

Click to view dynamic map

9240 Santa Fe Springs Road,
Santa Fe Springs, CA 90670

Contact: Eric Lindsay - General Manager
Tel: +1 562 948 2225

Fax: +1 562 948 5850

Email: americas@exova.com

Capabilities
Click to view dynamic map

Plot 598-221, Dubai Investments Park 1, The Green Community, P.O. Box: 34924,
Dubai

Contact: Jason Dodds - Managing Director
Tel: +971 4 885 1001

Fax: +971 4 885 4004

Email: middle.east@exova.com

Click to view dynamic map