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DCTI offer complete stability services and support customers at various stages of their drug product lifecycle e.g., API’s and finished dosage forms oral formulations (Tablets, Capsules, syrups and PFOS), Injectable (Liquid and suspensions), Topicals, Inhalations and Ophthalmic products.
- Early stage development (Phase I to Phase IV)
- Clinical supplies
- Formulation development
- Validation batches
- Exhibit/submission batches
- Commercial batches
- World best class stability chambers (Binder make) are installed at DCTI and chambers are monitored/alarmed through computerized systems. All the stability chambers have 24×7 backup power supply.
- Stability studies can be conducted as per ICH preferred stability conditions e.g.., 25℃/60%RH; 30℃/65%RH; 40℃/75%RH; 2-8 ℃; -20℃ or as per customer requirements.
- 600 Square feet room space available for future expansion to accommodate walk-in chambers.
- Stability studies are monitored by well-established quality SOPs and through concurrent documentation of loading and withdrawal of stability samples from the chambers
- Efficient and scientifically driven OOS and OOT investigation processes established using robust quality systems.