Impurity Profiling: A Review
DOI:
https://doi.org/10.22270/ajprd.v10i2.1052Keywords:
Impurities, Solvents, Guidelines, Control, Quantification, Existence, Efficacy.Abstract
Impurities are any substances, such as starting materials or intermediates, that coexist with the parent drug or arise from side reactions. Interest in impurities present in APIs continues to grow. Nowadays, not only purity profile but also impurity profile is mandated by various regulatory agencies. Impurity profiling is a generic name for a group of analytical working groups such as describing, quantifying and characterizing identified and unidentified impurities present in a new drug substance. Impurity profiling is a novel approach aimed at detecting, identifying, structuring and quantifying organic and inorganic impurities and residual solvents in pharmaceuticals. Various regulatory bodies, such as ICH, USFDA, UKMHRA, and India's CDSCO, focus on impurity profiling and have formulated guidelines for impurity management and restriction. Impurities are classified into different categories based on their origin, type of composition, and biological safety. The presence of these unwanted chemicals or substances may affect the safety and effectiveness of the final medicinal product. This review focuses on the sources of impurities, their classification, and various analytical methods for the identification and quantification of impurities. Terms such as residual solvent, by-product, transformation product, decomposition product, reaction product, and related products are often used to define impurities.
Downloads
References
2. Dhavale Om Manikrao and Katkar Chaitanya Pradip,Review On Impurity Profiling, World Journal of Pharmaceutical Research 2020; 9:417.
3. Rishi Ram Parajulim, Priyanka Pokharel, Mukem Bhattaraiand Dr. Bhupendra Shrestha,Impurity profiling: An emerging approach for pharmaceuticals, World Journal of Pharmacy and Pharmaceutical Sciences 2018; 7:1670
4. Jadhav Ankush P., Kedar Tejashree R., Gaikwad Vishal S., Jadhav Ravindra T., Recent approaches for Impurity Profiling-A review 2020; 5:111.
5. Dr. Sayyed Hussain, Dr. Amit Gosar and Tabrez Shaikh, Impurity Profiling in Pharmaceuticals: A Review,World Journal of Pharmaceutical Research 2018; 7:305.
6. P.Venkatesan and K.Valliappan,Impurity Profiling: Theory and Practice, Journal of Pharmaceutical Science and Research 2014; 6:254.
7. Dorottya Bartos and Sandor Gorog,Recent Advances in the Impurity Profiling of Drugs,Current Pharmaceutical Analysis, 2008; 4:215.
A. Ayre, D. Varpe, R. Nayak, N. Vasa,Impurity Profiling of Pharmaceuticals, A Peer Reviewed International Journal for Pharmaceutical and Allied Research 2011; 1:76.
8. Warad T.A., BhusnureO.G., Gholve S.B., Impurity Profile of Pharmaceutical Ingredients: A Review,Journal of Pharmacy Research, 2016; 10:523-533.
9. Ashish Garg, Sweta Garg, Vishal Singh, Ajay Shukla, Impurity Profile Study: A Quality Control tool for Pharmaceuticals, Asian Journal of Biomaterial Research 2016; 2:89.
10. Shashank Rawat and Vijay Kumar, Impurity Profiling: Overview on Impurity Profiling and Reporting Methodologies Adopted by United States and Europe, World Journal of Pharmaceutical Research 2017; 6:206-207.
11. Gupta Raghav, Dr. Jain Suresh, Gupta Ankit, A Review on Impurity Profile of Pharmaceuticals, International Journal of Drug Formulation and Research 2014; 5:60-61.
12. BariS.B., Jain P.S., Shirkhedkar A.A., Sonawane L.V., Mhaske A.J., Gawad J.B., Impuritiesin Pharmaceutical: A Review,World Journal of Pharmaceutical Research 2015; 4:2936-2937.
13. Rajveer Bhaskar, Monika Ola, Prakash H. Patil and Rishikesh D. Shinde, Impurity Profile: An Overviewin Pharmaceuticals, World Journal of Pharmaceutical Research 2016; 5:388-390.
14. S. V. Saibaba, M. Sathish Kumar and B. Ramu, Pharmaceutical Impurities andtheir Characterization: A Review, European Journal of Pharmaceutical and Medical Research 2016; 3:191.
15. Ms. Meera S. Honrao,Impurity Profile: A Review, Pharmainfo.net 2005; 3.
16. Durgesh Nandkishor Boob, Santosh Dattu Navale, Manoj Mahale, Machindra Jayram Chavan,A Review on Impurities Profiling in Pharmaceutical Analysis, American Journal of Pharmaceutical Research 2003; 3:29-31.
17. A.K. Landge, V.K. Deshmukh, S.R. Chaudhari, Impurities in Pharmaceuticals- A Review, Journal of Current Pharma Research 2013; 4:1112-1114.
18. Anita Singh, Sadaf Afreen, Dhirendra Pratap Singh and Rajeev Kumar, A Reviewon Pharmaceutical Impurities and their Importance, World Journal of Pharmacy and Pharmaceutical Sciences2017; 6:1351.
19. Anurag Jain, Sanjay Sharma, Recent trends in impurity profiling of pharmaceutical products 2017; 3:4-5.
20. Dr. K. Mangamma, B.T. Anil Kumar, Yenduri Leela Priyanka and Akkala Sai Veneela, Impurity Profiling of Pharmaceuticals – A Review, World Journal of Pharmaceutical Research 2019; 8:436.
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).