Laboratory Testing Services

Stability Studies

Medipharm Laboratories conducts both long-term stability studies and accelerated studies to determine a product's shelf-life and expiration dates. We have extensive experience in working with many dosage forms including liquids, ointments, creams, capsules, and tablets.

In a typical three-month accelerated study, a sufficient number of samples are forced to high temperature and humidity storage conditions. One sample is selected every thirty days for physical, chemical, and microbiological testing to determine its retention of the same properties and characteristics that it had when it was packaged.

For long-term studies, samples are tested every three months for one year, every six months during the second year, and once a year during the third year and subsequent years.

Medipharm's precise stability chambers maintain the temperature and humidity conditions during the studies. Our calibrated instruments quantify the potency of the selected analyte with high precision and reproducibility in each step of the protocol.

All conditions are logged to provide a continous record of compliance. Your stability studies are safe and secure with our alarm notification system.

All maintenance and service is provided by qualified engineering support. Maintenance records and monitoring data can be viewed during an audit.