AQUEOUS STABILITY

A compound that is intrinsically unstable are not suitable for drug development. Unstable compounds have very low shelf life. Oral bioavailability is affected for compounds with poor stability at low pH. 


An early assessment of compound stability in both aqueous and organic environments is highly recommended. Aqueous stability is measured in relevant biological fluids.


Stability assay protocol:

  

Method: Buffer shake flask method

Test article concentration: 1 µM (other upon request)

Incubation time: t = 0, 15, 30, 60 and 120 minutes (as per request) 

Incubation temperature: 37 C (as per request) 

Number of Replicates: 

n = 2 (aliquots from buffer samples) 

Assay condition: PBS - pH 7.4 (other buffers upon request) 

Positive control: Omeprazole 

Analysis Method: LC/MS/MS 

Data Delivery: % parent remaining at time t and or Half life