What is Stability?

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What is STABILITY AND STABILITY TESTING?

 

The purpose of stability testing is to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light.

Product-related factors influence the stability. For example, the chemical and physical properties of the active substance and the pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system, and the properties of the packaging materials. Also, the stability of excipients that may contain or form reactive degradation products must be considered.

Our suite of stability products can help you organize, analyze, and report stability storage and testing information in an efficient, user-friendly manner.  Schedule a demo with us to see how!

STABILITY LABORATORY DATABASE MANAGER

Commercial off-the-shelf solution for complete management of your drug stability program.

INTUITIVE SHELF-LIFE PROJECTION SOFTWARE

Developed specifically to determine the shelf-life of drug products placed on stability.

VALIDATED & CUSTOMIZABLE REPORT GENERATION

Seamless generation of validated stability reports in a format ready for FDA submission.

DEDICATED TO CONTINUOUS IMPROVEMENT

Designed to maintain compliance with requirements of the FDA and GAMP.