Impurity Profiling

List of Practicals

1. Identification of organic impurities in bulk drugs using TLC
2. Quantification of impurities using HPLC
3. Determination of residual solvents by GC (as per ICH Q3C)
4. UV-spectrophotometric analysis of degradation products
5. Preparation of forced degradation samples (acid/base/hydrolytic)
6. Identification of degradation products via IR spectroscopy
7. Extraction and analysis of impurities from finished dosage forms
8. Impurity profiling of marketed paracetamol tablet using HPLC
9. Qualification of impurities as per ICH Q3A/Q3B guidelines
10. Limit test for heavy metals (as per IP)
11. Estimation of elemental impurities by ICP-MS or simulated method
12. Determination of related substances in antibiotics (e.g., cephalosporins)
13. Impurity profiling of herbal products using HPTLC
14. Report preparation on impurity profiling as per regulatory requirements