Test Services

Stability Testing

BACKGROUND

When a claim of stability is made, that is outside the standards delineated in the USP <797> for low, medium and high risk compounds, the claim must be validated with testing. The criteria that can directly impact stability are:

• Compound Formula
  
• Compounding Process
  
• Container Closure System
  
• Handling and Storage Conditions

Once a claim has been validated, any significant changes in these criteria may require some level of revalidation. This may not mean all the original validation testing be conducted, however there may need to be some smaller subset of the testing that needs to be repeated.

In additions to claims made on end use doses, there may also be claims made on intermediate materials that are maintained within the pharmacy, that are used in the compounding of end use doses. These must also be included in the design of the stability testing program.

OUR METHODOLOGY

DYNALABS will work with the customer to create individual stability programs for specific compounds however, we prefer to work with the customer to first create families of compounds based on formula, compounding processes, container closure system, and handling and storage conditions. We then apply our considerable experience and knowledge to design of a testing program that minimizes the costs of implementing a stability program, while maximizing the value gleaned from the data created.

FORMS TYPICALLY TESTED

• All sterile and non sterile forms for which DYNALABS has testing methods.