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Title: :  PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE
PaperId: :  28097
Published in:   International Journal Of Advance Research And Innovative Ideas In Education
Publisher:   IJARIIE
e-ISSN:   2395-4396
Volume/Issue:    Volume 12 Issue 1 2026
DUI:    16.0415/IJARIIE-28097
Licence: :   IJARIIE is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Author NameAuthor Institute
Ms. Dhanashri Bhonde Vidyabharati college of pharmacy, Amravati
Dr. S.G.JawarkarVidyabharati college of pharmacy, Amravati
Ms. Eshika DeshmukhVidyabharati college of pharmacy, Amravati
Ms. Diksha PatilVidyabharati college of pharmacy, Amravati

Abstract

pharmacy
Impurities, API, QSAR, Machine learning, AI, ICH guidelines, Impurity profiling,Impurity prediction
Controlling impurities in Active Pharmaceutical Ingredients (APIs) remains a key challenge due to complex synthesis routes, diverse contamination sources, and limitations of traditional analytical methods. With increasing demand for safer medicines, Artificial Intelligence (AI) is becoming a valuable tool for predicting, identifying, and monitoring impurities more efficiently. Techniques such as machine learning, deep learning, QSAR modeling, and reaction-prediction algorithms are now integrated with analytical platforms like HPLC, LC–MS, GC–MS, NMR, and PAT to improve impurity profiling. AI can analyze large datasets, detect hidden patterns, and predict degradation pathways and genotoxic risks in advance. Applications including retention-time prediction, ICH M7-based mutagenicity assessment, and AI-assisted stability studies demonstrate its growing practicality. Despite challenges such as limited data quality, model transparency, and regulatory adaptation, the integration of AI with automation and digital technologies offers strong potential for real-time impurity control and improved quality-by-design approaches in pharmaceutical development.

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IJARIIE Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil. "PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE" International Journal Of Advance Research And Innovative Ideas In Education Volume 12 Issue 1 2026 Page 1208-1220
MLA Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil. "PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE." International Journal Of Advance Research And Innovative Ideas In Education 12.1(2026) : 1208-1220.
APA Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, & Ms. Diksha Patil. (2026). PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE. International Journal Of Advance Research And Innovative Ideas In Education, 12(1), 1208-1220.
Chicago Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil. "PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE." International Journal Of Advance Research And Innovative Ideas In Education 12, no. 1 (2026) : 1208-1220.
Oxford Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil. 'PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE', International Journal Of Advance Research And Innovative Ideas In Education, vol. 12, no. 1, 2026, p. 1208-1220. Available from IJARIIE, http://ijariie.com/AdminUploadPdf/PREDICTION_OF_API_IMPURITIES_USING_ARTIFICIAL_INTELLIGENCE_ijariie28097.pdf (Accessed : ).
Harvard Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil. (2026) 'PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE', International Journal Of Advance Research And Innovative Ideas In Education, 12(1), pp. 1208-1220IJARIIE [Online]. Available at: http://ijariie.com/AdminUploadPdf/PREDICTION_OF_API_IMPURITIES_USING_ARTIFICIAL_INTELLIGENCE_ijariie28097.pdf (Accessed : )
IEEE Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil, "PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE," International Journal Of Advance Research And Innovative Ideas In Education, vol. 12, no. 1, pp. 1208-1220, Jan-Feb 2026. [Online]. Available: http://ijariie.com/AdminUploadPdf/PREDICTION_OF_API_IMPURITIES_USING_ARTIFICIAL_INTELLIGENCE_ijariie28097.pdf [Accessed : ].
Turabian Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil. "PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE." International Journal Of Advance Research And Innovative Ideas In Education [Online]. volume 12 number 1 ().
Vancouver Ms. Dhanashri Bhonde , Dr. S.G.Jawarkar, Ms. Eshika Deshmukh, and Ms. Diksha Patil. PREDICTION OF API IMPURITIES USING ARTIFICIAL INTELLIGENCE. International Journal Of Advance Research And Innovative Ideas In Education [Internet]. 2026 [Cited : ]; 12(1) : 1208-1220. Available from: http://ijariie.com/AdminUploadPdf/PREDICTION_OF_API_IMPURITIES_USING_ARTIFICIAL_INTELLIGENCE_ijariie28097.pdf
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