JavaScript is disabled. Please enable to continue!
Francais
Print Page

Save this page as a PDF

Mobile search icon
Menu
Our Services >> Pharmaceutical Testing >> Full ICH Stability Studies

Stability Study Testing Programs

Search >>

Stability Study Testing Programs | Toronto, Ontario

What is a stability study?

A stability study is an examination of a substance or product over a specified period of time to examine the effects under defined storage conditions monitoring the characteristics of this substance or product. This test essentially generates data to support the product’s shelf life.

Eurofins BioPharma Product Testing Toronto Inc has a wide range of specialized conditions with cGMP storage and testing options for marketed products and critical reference materials.

Stability studies are used to ensure a product retains its physical, chemical, and microbiological properties as specified at the time of packaging. This includes shelf-life testing to either establish a new expiry date for a new product or data collection in the ongoing support of existing expiry dates for the finished product (FP) or active pharmaceutical ingredient (API).

All chambers are housed in secure areas with continuously monitored redundant controls (24/7). Chambers are supported with a backup generator and a fully validated computerized stability LIMS system to manage studies.

Study progress monitored locally by the client through an online data access Stability portal.

  • Design and establish a stability program for your FP or API to comply with ICH (Q1) requirements which includes protocol development, specifications, sample storage, and testing
  • We can execute client methods, protocols, and specifications and is also capable of development and validation of methods for analysis
  • Freeze-thaw studies to assess the impact of temperature excursions on product
  • Preparation of preliminary reports for each study period
  • Preparation of final report on the stability study and the evaluation of the results obtained

 

Study

Stability Conditions

Long-term

(determined by the defined climatic condition)

25°C/60%RH

5°C ± 3°C

-20°C ± 5°C

Intermediate

30°C/65%RH

Accelerated

40°C ± 2°C/ 75%RH ± 5%RH

Conditions for other climatic zones, custom conditions, and photostability are also available!

Support Services Offered

  • Release Testing
  • Support of Method Development/Validation
  • Protocol Writing
  • Storage & Distribution of Reference Materials
  • Sample Retain Program Management
  • Capability to Store and Analyze Controlled Substances
  • Photostability Studies
  • Storage Only