This function focuses on stress testing APIs and drug products to identify degradation pathways, determine potential impurities, and ensure the stability and safety of pharmaceutical compounds. Data from these studies support formulation development, shelf-life determination, and regulatory submissions.
Key Deliverables
- Forced Degradation Studies: Subjecting APIs, intermediates, and formulations to stress conditions such as heat, light, humidity, oxidation, and pH extremes.
- Degradation Pathway Analysis: Identifying and characterizing degradation products and understanding their formation mechanisms.
- Impurity Profiling & Identification: Using HPLC, LC-MS, NMR, and other techniques to detect and characterize degradation products.
- Stability Prediction: Informing formulation strategies and storage conditions based on degradation behavior.
- Regulatory Support: Providing data and reports for IND, NDA, ANDA, and DMF submissions, demonstrating robustness and product stability.
- Quality Assurance Integration: Ensuring forced degradation data supports ongoing batch release and shelf-life monitoring.