Stability data for DEFRATAJ Deferasirox dispersible tablets is generated under ICH Q1A(R2) long-term, intermediate and accelerated conditions, with climatic-zone configurations appropriate to the intended markets. Stability supports the declared shelf life and in-use recommendations on the approved label.
ICH Storage Conditions #
| Condition | Temperature / Humidity | Minimum Duration |
|---|---|---|
| Long-term (Zone II) | 25 degrees C +/- 2 / 60% RH +/- 5 | 12, 24, 36 months (up to declared shelf life) |
| Long-term (Zone IVa) | 30 degrees C +/- 2 / 65% RH +/- 5 | 12, 24, 36 months |
| Long-term (Zone IVb) | 30 degrees C +/- 2 / 75% RH +/- 5 | 12, 24, 36 months |
| Intermediate | 30 degrees C +/- 2 / 65% RH +/- 5 | 6 months |
| Accelerated | 40 degrees C +/- 2 / 75% RH +/- 5 | 6 months |
Test Parameters Monitored During Stability #
- Appearance of tablet and secondary packaging
- Assay of Deferasirox (HPLC)
- Related substances / impurities (ICH Q3B thresholds)
- Dissolution profile
- Disintegration time
- Water content (Karl Fischer)
- Microbial limits (at long-term time points)
- Packaging integrity (as applicable)
Packaging-Specific Studies #
Stability programmes are run on each pack configuration intended for marketing - PVC/PVDC-Aluminium blister, Aluminium-Aluminium blister (where used), HDPE bottle + induction seal + desiccant. Photostability is evaluated per ICH Q1B where relevant. In-use stability for multi-dose bottle presentations is studied and declared on the label.
Shelf Life Justification #
The declared shelf life (typically 24-36 months depending on strength and market) is supported by regression analysis of long-term data, with bracketing and matrixing applied per ICH Q1D where appropriate. Out-of-trend and out-of-specification results during stability trigger full investigation.
On-Going Stability #
An on-going stability programme places at least one batch per strength per year into long-term conditions to verify the continued validity of the declared shelf life and detect any process-drift early. Results are reviewed at the Annual Product Quality Review.
Data Package for Dossier #
Full stability data is included in Module 3.2.P.8 of the CTD dossier, with study protocols, tabulated results, trend analyses and stability commitment. Available on request under CDA.