Stability Studies

Stability, also known as Shelf-Life, refers to how long a product retains, according to specified limits throughout storage and use, the same properties and characteristics that it possessed at the time it was packaged. AAL recognizes two types of stability for its products:

  1. Chemical Test: Chemical integrity and potency within specified limits.
  2. Physical Test: Retention of physical properties, including appearance, taste, odor, and wholesomeness.

 

Stability studies include:

  • Microbiological Analysis
  • High Pressure Liquid Chromatography (HPLC) Analyses
  • Chemical Analyses
  • USP Chemical Analyses

 

Stability Storage

Stability Storage is structured as multiple chambers, which are designed to meet various temperature conditions, required by FDA and ICH, as well as other conditions required specifically by the client. All of our storage chambers are continuously monitored by a computerized system, with temperature and humidity set-point windows at ±2° C and ±5°RH.

 

Temperature Control/Ambient

2° C
25° C
40° C

Temperature/Humidity Controls

25° C/60%RH
40° C/75%RH

 

All of our Stability Storage settings are in concordance with ICH and FDA guidelines.

 

AAL’s experience with IND and NDA Projects:

  • Accelerated Stability Testing
  • Long Term Stability Testing
  • IND, NDA, ANDA Stability
  • Protocol Design for R&D Stability and Formulation
  • Dissolution Stability

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