ARL has extensive experience in conducting stability studies for numerous types of drugs in different matrices and different conditions. ARL understands the FDA requirements and can also provide easy to read stability study reports. The following stability testing services are provided by ARL:

• Stability of pharmaceutical ingredients (API and excipients)
• Product release stability testing
• Stability of clinical trial material
• Shelf-life dating
• Physical compatibility testing (drug-drug interaction, Y-Site compatibility)

Stability is defined as the extent to which a product retains, within specified limits, and throughout its shelf-life, the same properties and characteristics that it possessed at the time of its manufacture or compounded.  ARL offers you three types of stability as shown in the table.

The scope and design of a stability study vary according to the product and the manufacturer concerned. Ordinarily, one or more formulations of each dosage form are prepared, packaged in suitable containers, and stored under a variety of environmental conditions, both accelerated (40°C / 75% RH and/or 30°C / 65%RH) and ambient (25°C / 60%RH).  At appropriate time intervals, samples of the product are assayed for potency by use of a stability-indicating method, observed for physical changes, and, where applicable, tested for sterility and/or for resistance to microbial growth and for toxicity and bioavailability. Such study, enables the client to assign recommended storage conditions and an expiration date / beyond use date for each dosage form in its package.