Stability Studies

Comprhensive Stability Testing for Long-Term and Accelerated Studies

Medipharm Laboratories, Inc. 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 six months accelerated study a sufficient number of sample bottles are forced to both high temperature (40 °C) and 75 % of relative humidity (RH) storage conditions. For the first three months of the study a sample is analyzed every thirty days according to the tests included in the study protocol. Final interval for testing would be done at 180 days. The results would be evaluated to conclude if the product retains the same properties, characteristics, and concentration of its active ingredients (if any) 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 and subsequent years. 

Medipharm Laboratories, Inc.’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 each step of the protocol. 

All conditions are logged to provide a continuous 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.