In multidose products (bottles for tablets or capsules, eye drops, nasal spray, etc.) in which the patient manipulates them for its administration, it is needed to confirm that the product remains stable by simulating the instructions of use described in the labelling.
For products that have to be reconstituted or diluted previous to administration (injectable for intravenous perfusion or lyophilised), the in-use stability must be also demonstrated.
In all these cases an in-use stability study must be carried out. This study must be carried out not only at initial time (t=0) but also for shelf-life.
What is needed for these studies?
For these studies qualified and calibrated climatic chambers as well as the GMP certification are necessary.
What Netpharmalab offers to you…
At Netpharmalab we offer the possibility to store the samples in the different climatic chambers as well as the analysis of these samples according to the in-use stability protocol.
The different climatic chambers for these studies that we offer are:
- 25ºC/ 60% RH
- 30ºC/ 65% RH
- 30ºC/ 75% RH
In addition, at Netpharmalab we prepare the protocols, the results summaries, the reports and the stability tables according to the GMP.