Main Article Content


The objective of the review article is to give detailed description and guidance of the forced degradation studies as per regulatory guidelines. Forced degradation study provide information about the degradation pathways and degradation products of the drug substance and helps in the elucidation of the structure of the degradation products. forced degradation study provide the chemical behaviour and chemical nature of the molecule which ultimately helps in the development of formulation during manufacturing and packaging specification, thus this review article provide knowledge of the current trends in performance of forced degradation study and establishing the analytical methods that helpful for development of stability indicating method. The stability of drug product and or drug substance is a critical parameter which may affect purity, potency and safety.


Degradation Purity Potency

Article Details

How to Cite
Mrs. Khushbu A. Thakor, Dhara D. Bhavsar, & Jagruti R. Thakor. (2021). A review article – development of forced degradation and stability indicating studies for drug substance and drug product. International Journal of Research in Pharmacology & Pharmacotherapeutics, 5(4), 291-297. Retrieved from


  1. [1]. Singh R Current trends in forced degradation study for pharmaceutical product development. Journal of pharmaceutical and educational research. 2, 2012, 54-63.
  2. [2]. Hotha K Forced degradation studies: Practical Approach- Overview of regulatory guidance and literature for the drug products and drug substances. International Research journal of pharmacy. 4, 2013, 78-85.
  3. [3]. Blessy M Development of forced degradation and stability indicating studies of drugs- A review. Journal of pharmaceutical analysis. 4, 2014, 159-165.
  4. [4]. Rawat T Forced degradation studies for drug substances and drug products- Scientific and Regulatory considerations. Journal of Pharmaceutical science and research. 7, 2015, 238-241.
  5. [5]. Singh S Guidance on conduct of stress tests to determine inherent stability of drugs. Pharma Tech. 24, 2000, 1-14.
  6. [6]. ICH guidelines, Q1A (R2): Stability testing of New drug substances and products, International council on Harmonization.
  7. [7]. ICH Harmonised Tripartite Guideline stability testing: Photostability testing of new drug substances and products Q1 B.
  8. [8]. Brummer H How to approach a forced degradation study. Life Sci. Technol. Bull. 31, 2011, 1-4.
  9. [9]. Maheswaran R FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA Submissions. Pharmaceutical Technology. 36, 2012, 73-80.
  10. [10]. Reynolds D et al. Available guidance and best practices for conducting forced degradation studies. Pharm Tech. 26, 2002, 48-56.
  11. [11]. Kats M Forced degradation studies: regulatory considerations and implementation. Bio Pharm Int.18, 2005, 1-7.
  12. [12]. Ngwa G Forced degradation studies as an integral part of HPLC stability indicating method development. Drug Deliv. Technol. 10, 2010, 56-59.
  13. [13]. Klick S Toward a generic approach for stress testing of drug substances and drug products. Pharm. Technol. 29, 2005, 48-66.
  14. [14]. Boccardi G Oxidative susceptibility testing, 220. In pharmaceutical Stress Testing-Predicting Drug Degradation. Taylor and Francis.2005.
  15. [15]. Bojana P Microwave-assisted forced degradation using high-throughput microtiter platforms. J Pharmaceut Biomed 56, 2011, 867-873.
  16. [16]. Bakshi M Development of validated stability-indicating assay methods-critical review. Journal of Pharmaceutical and Biomedical Analysis 28, 2002, 1011–1040.
  17. [17]. Jain D Forced degradation and impurity profiling: Recent trends in analytical perspectives. Journal of Pharmaceutical and Biomedical Analysis 86, 2013, 11–35.
  18. [18]. Basha M A review on forced degradation studies and its Importance in analytical method development and validation. International Journal of innovative Parmaceutical sciences and Research 2, 2014, 2929-2940.