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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:
- Chemical Chemical integrity and potency
within specified limits
- Physical 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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