A Review on Multi Approaches for Impurity Isolation and its Characterization

  • Pintu B. Prajapati
  • Navneet Wankhed
  • Priti J. Mehta

Abstract

International Conference on Harmonization (ICH) has formulated different guideline regarding the control of impurities. In this review,  the impurity sources, classification, isolation, detection and characterization methods are described. The some impurities are unavoidable and will be present in trace amounts hence ICH guidelines frame the different policies and establish the specification limits, isolation and characterization is necessary for evaluation and control of impurities. The other regulatory bodies and drug development authorities look up to these guidelines for launching a quality drug into the market. Validation of analytical process for impurity identification is performed to establish the impurity profile of any drug substance. Hence the major focus of this review article is on isolation and characterization of impurities using various technics, sources and classifications, establishment of impurity profile and analytical approaches to establish its profile. We also could apply the QbD to providing statistical documentary evidences.


Keywords: Impurity profile, Impurities isolation methods, chromatographic separation, Impurity Characterization, ICH, QbD.

Downloads

Download data is not yet available.

References

1. Agency, E. M. (2006) “ICH Topic Q 3 B (R2) Impurities in New Drug Products,” EMEA European Medicines Agency, (August 2003).
2. Alsante, K. M. et al. (2001) “Isolation and Identification of Process Related Impurities and Degradation Products from Pharmaceutical Drug Candidates, Part I,” American Pharmaceutical Review, 4(1), pp. 70–78.
3. Ashraf-Khorassani, M. et al. (2005) “Purification of pharmaceutical excipients with supercritical fluid extraction,” Pharmaceutical Development and Technology, 10(4), pp. 507–516. doi: 10.1080/10837450500299958.
4. Ayre, A. et al. (2011) “Impurity profiling of pharmaceuticals,” Advance research in pharmaceuticals and biologicals, 1(2), pp. 76–90.
5. Bari, S. et al. (2007) “Impurity profile: Significance in Active Pharmaceutical Ingredient,” Eurasian Journal of Analytical Chemistry, 2(1), pp. 32–53. doi: 10.12973/ejac/78054.
6. Bari, S. et al. (2015) “Impurities in pharmaceuticals: A review,” World Journal of Pharmaceutical Research, 4(10), pp. 2932–2947.
7. Deshpande, P. B. et al. (2012) “Supercritical Fluid Technology: Concepts and Pharmaceutical Applications,” PDA Journal of Pharmaceutical Science and Technology, 65(3), pp. 333–344. doi: 10.5731/pdajpst.2011.00717.
8. Findlay, W. P. (no date) “Vibrational Spectroscopy,” (5).
9. Gabhe, S., Desai, S. and Patel, A. (2011) “Isolation and characterization of impurities present in 8-chlorotheophylline,” Indian Journal of Pharmaceutical Sciences, 73(1), p. 79. doi: 10.4103/0250-474x.89762.
10. ICH, A. (2006a) “Impurities in New Drug Products Q3B(R2),” in International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use, pp. 1–30. doi: 10.1017/CBO9781107415324.004.
11. ICH, A. (2006b) “Impurities in New Drug Substances Q3A(R2),” in International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use, p. 15.
12. Ingale, S. J. et al. (2011) “Advance approaches for the impurity profiling of pharmaceutical drugs : A review,” International Journal of Pharmacy & Life Sciences, 2(7), pp. 955–962.
13. Kulkarni, A. (2018) “Impurity: Pharma Market and Importance,” MOJ Bioorganic & Organic Chemistry, 1(4), pp. 128–129. doi: 10.15406/mojboc.2017.01.00023.
14. Palve R. et. al. (2018) “A Review on Impurity Profile in Pharmaceutical Substances,” Research and Reviews Journal of Pharmacy and Pharmaceutical Sciences, 13(1).
15. Pawale, S. S., Saley, S. P. and Tilloo, S. K. (2012) “Impurity Profile in Bulk Drugs and Pharmaceutical,” 1(4), pp. 1227–1237.
16. Prafulla Kumar Sahu, S. S. (2015) “An Overview of Pharmaceutical Impurities and Degradation Products,” Pharmaceutical Regulatory Affairs: Open Access, 04(01), p. 7689. doi: 10.4172/2167-7689.1000e148.
17. Saibaba, S. V, Kumar, M. S. and Ramu, B. (2016) “Pharmaceutical Impurities and Their Characterization : a Review,” European Journal of Pharmaceutical and Medical Research, 3(5), pp. 190–196.
18. Savkare A. D, B. N. R. (2016) “Comprehensive approach of QbD for impurities in drug substances and drug products,” Indo American Journal of Pharmaceutical Sciences, 3(2), pp. 81–85.
19. Singh, A. et al. (2017) “A review on Pharmaceutical Impurities and Their,” World Journal of Pharmacy and Pharmaceutical Sciences, 6(10), pp. 1337–1354. doi: 10.20959/wjpps201710-10280.
20. Venkata Pavan Kumar G. Prameela Rani, A., Pooja, B. and Anil Kumar, Y. (2016) “Phytochemical Screening, Spectroscpic Characterisation and Cardiotonic Activity of Aqueous Extract from Arieal Parts of Carmona Retusa (Vahl) Masam on Isolated Frogs Heart,” International Journal of Pharmaceutical Chemistry, 3. doi: 10.7439/ijpc.
21. Venkatesan, P. and Valliappan, K. (2014) “Impurity profiling: Theory and practice,” Journal of Pharmaceutical Sciences and Research, 6(7), pp. 254–259.
22. Vijayalakshmi R, K. S. and S. A. (2012) “Scientific Approaches for Impurity Profiling in New Pharmaceutical substances and its products- An overview,” International Journal of Pharmaceutical and Chemical Sciences, 1(1), pp. 386–403.
Statistics
53 Views | 83 Downloads
How to Cite
1.
Prajapati PB, Wankhed N, Mehta PJ. A Review on Multi Approaches for Impurity Isolation and its Characterization. JDDT [Internet]. 30Aug.2019 [cited 24Oct.2020];9(4-A):793-02. Available from: http://www.jddtonline.info/index.php/jddt/article/view/3627