Introduction

Drug stability is one of the most often studied characteristics in pharmaceutical testing.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

Proper design, implementation, monitoring and evaluation are important for obtaining useful and accurate stability data. Stability studies are linked to the establishment and assurance of safety, quality and efficacy of the drug product from early phase development through the lifecycle of the drug product. Stability data for the drug substance / drug products are used to determine the physico-chemical stability profile for the compound. From this information, optimal storage and packaging conditions can be assessed; the appropriate retest intervals and criteria can be established for bulk lots of the material.

The stability studies for the drug substance / product are designed to determine the expiration date (or shelf life). In order to assess stability, the appropriate physical, chemical, biological and microbiological testing must be performed.

For more information on the stability studies of the drug substance / drug products  CLICK HERE

Stability Studies Research Library:

Poor validation, stability studies net Searle 10-item 483.: An article from: Validation TimesThis digital document is an article from Validation Times, published by Washington Information Source on April 1, 2004. The length of the article is 7... Read More >

Temporal stability of the timeline followback interview for alcohol and drug use with psychiatric outpatients *.: An article from: Journal of Studies on AlcoholThis digital document is an article from Journal of Studies on Alcohol, published by Alcohol Research Documentation, Inc. on November 1, 2004. The len... Read More >

Colombian Labyrinth: The Synergy of Drugs and Insugency and Its Implications for Regional StabilityU.S. policy toward Colombia has been driven to a large extent by counter-narcotics considerations, but the evolving situation in that South American c... Read More >

Protocols for stability and homogeneity studies of drugs for its application to doping control [An article from: Analytica Chimica Acta]This digital document is a journal article from Analytica Chimica Acta, published by Elsevier in 2004. The article is delivered in HTML format and is ... Read More >

Searle lands 10-item 483 for shoddy stability, validation studies.(Human Drugs): An article from: Inspection MonitorThis digital document is an article from Inspection Monitor, published by Washington Information Source on March 1, 2004. The length of the article is... Read More >