Core Capabilities

In Use Stability

Stabilità in uso

“In-use conditions are defined as the conditions that mimic the intended use of the drug product after the primary container is first breached and, where applicable, through preparation, storage and administration as per the relevant instructions.” (ICH Q1 Guideline on stability testing of drug substances and drug products_Step 2b) 

 

Many diluents, such as 

  • NaCl 0.9%
  • Dextrose 5%
  • Ringer 
  • Ringer Lactated
  • Lidocaine
  • And so on…

 

ALL THE PREPARATIONS ARE STORED AT DIFFERENT CONDITIONS, THAT REFLECT THE INSTRUCTION FOR USE 

Temperature:

 Humidity:

 Time points:
+25°C
+40°C
+5°C
-20°C		 60% RH
75%RH		 Hours
Days
Weeks

“An in-use study should demonstrate that the drug product remains stable and does not negatively impact the device delivering the drug during the in-use duration.” (ICH Q1 Guideline on stability testing of drug substances and drug products_Step 2b) 

 

A series of analyses are performed at eacht time point to assure the quality of the product, such as assay, related substances, color, PM, pH. 

After the study, the product leaflet can be update with the new tested conditions.