Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Review Article

Impurity Profiling-A Significant Approach in Pharmaceuticals

Author(s): Dipankar Nath* and Bidhya Sharma

Volume 15, Issue 7, 2019

Page: [669 - 680] Pages: 12

DOI: 10.2174/1573412914666181024150632

Price: $65

Abstract

There has been ever increasing interest in impurities present in Active Pharmaceutical Ingredient’s (API’s). Nowadays, not only purity profile but also impurity profile has become mandatory according to the various regulatory authorities. In the pharmaceutical world, an impurity is considered as an inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arising out of synthesis or unwanted chemicals that remains with APIs. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulation. The control of impurities in Formulated products and API’s were regulated by various regulatory authorities like ICH, USFDA, Canadian Drug, and Health Agency. Impurity profiling is very important in the modern pharmaceutical analysis due to the fact that unidentified, potentially toxic impurities are hazardous to health and in order to increase the safety of drug therapy, impurities should be identified and determined by the selective method. Nowadays, it is a mandatory requirement in various pharmacopeias to know the impurities present in APIs and finished drug products. Thus, impurity profiling can act as a Quality Control tool. It can provide crucial data regarding the toxicity, safety, various limits of detection and limits of quantitation of several organic and inorganic impurities, usually accompany with APIs and finished products. There is a strong requirement to have unique specifications/standards with regard to impurities.

Keywords: Drugs, impurity profiling, safety, analysis, ICH guidelines, pharmaceuticals.

Next »
Graphical Abstract

[1]
Chandra, S.M.; Singhai, A.K. Advances approaches for impurity profiling of pharmaceutical drug. Int. J. Pharm. Life Sci., 2011, 2(7), 955-962.
[2]
Victoria, S.F. Various aspects in the impurity profiling of pharmaceutical formulations. Pharm. Anal. Acta, 2014, 5, 8.
[3]
Anand, S.D.; Kalaskar, S.P. Recent advances in impurity profiling of pharmaceuticals. IJPSR, 2017, 8(8), 3206-3217.
[4]
Ramalakshmi, C.N.; Nalini, C.N.; Mahabubi, S. Impurity profiling an emerging trend in pharmaceuticals: A review. PharmaTutor, 2015, 3(11), 29-35.
[5]
European Pharmacopoeia, 4th Edition; Council of Europe: Strasbourg, France, 2004.
[6]
Qiu, Fenghe. Daniel, L. Norwood identification of pharmaceutical impurities. J. Liq. Chrom. Relat. Tech., 2007, 30(5-7), 877-935.
[7]
Drug characterization /impurity profiling manual for use by National Law Enforcement authorities and drug testing laboratories, UNODCCP
[8]
Victoria, S.F. Various aspects in the impurity profiling of pharmaceutical Formulations. Pharm. Anal. Acta, 2014, 5, 8.
[9]
Bari, S.B.; Kadam, B.R.; Jaiswal, Y.S.; Shirkhedkar, A.A. Impurity Profile: Significance in active pharmaceutical ingredient. Eur. J. Pharmaceut. Anal., 2007, 2(1), 33-53.
[10]
Nagpal, S. Karan, Upadhyay, A.; Bhardwaj, T.R.; Thakkar, A. A Review on need and importance of impurity profiling. Curr. Pharm. Anal., 2011, 7(1), 62-70.
[11]
Warad, T.A.; Bhusnure, O.G.; Gholve, S.B. Impurity profile of pharmaceuticals ingredient: A review. J. Pharm. Res., 2016, 10(7), 523-533.
[12]
Ahuja, S. Impurities Evaluation of Pharmaceuticals; Marcel Dekker, Inc.: New York, 2006.
[13]
Bartos, D.; Görög, S. Recent Advances in the Impurity Profiling of Drugs. Curr. Pharm. Anal., 2008, 4(4), 215-230.
[14]
Charde, M.S.; Kumar, J.; Welankiwar, A.S.; Chakole, R.D. Recent approaches for Impurity profiling of pharmaceuticals. Int. J. Adv. Pharmaceut., 2013, 2(3), 26-33.
[15]
Pawale, S.S. A review on significances of impurity profiling. Internat. J. Pharmaceut. Chem. Sci., 2012, 1(4), 1227-1237.
[16]
Parimoo, P. A Text Book of Pharmaceutical Analysis; CBS publishers and distributors, New Delhi, , 1998, p. pp. 140.
[17]
Parimoo, P. A Text Book of Pharmaceutical Analysis; CBS publishers and distributors, New Delhi, , 1998, p. pp. 20..
[18]
Ahuja, S. Impurities Evaluation of Pharmaceuticals; Marcel Dekker, Inc.: New York, 2006.
[19]
Ahuja, S. Handbook of Modern Pharmaceutical analysis; Academic press, 2001, p. 298.
[20]
Krimpen, P.C.; Bennekom, W.P.; Bult, A. Penicillins and cephalosporins: physicochemical Properties and analysis in pharmaceutical and biological matrices. Pharm. Weekbl. Sci., 1987, 9(1), 1-23.
[21]
Krimpen, P.C.; Bennekom, W.P.; Bult, A. Penicillins and cephalosporins: physicochemical Properties and analysis in pharmaceutical and biological matrices. Pharm. Weekbl. Sci., 1987, 9(1), 1-23.
[22]
Krimpen, P.C. Bennekom. W.P.; Bult, A. Penicillins and cephalosporins: physicochemical Properties and analysis in pharmaceutical and biological matrices. Pharm. Weekbl. Sci., 1987, 9(1), 1-23.
[23]
Vasanti, S.; Sulabha, S. Impurity profile-A review. Drug Invention Today., 2009, 1(2), 81-88.
[24]
Venkatesan, P.; Valliappa, K. Impurity profiling: Theory and practice. JPSR, 2014, 6(7), 254-259.
[25]
Ahuja, S.; Alsante, K.M. Handbook of isolation and characterization of impurities in pharmaceuticals; Amsterdam: Academic Press, 2005.
[26]
Ahuja, S. Impurities Evaluation of Pharmaceuticals; Marcel Dekker; 1998; New York, pp. 142..
[27]
Buhler, V. Vademecum for Vitamin Formulation. Stuttgart, Germany. Wiss Verl-Ges, 1998, 142, 36.
[28]
Ahuja, S. Impurities Evaluation of Pharmaceuticals; Marcel Dekker: New York, 1998, p. 142.
[29]
Food and Drug Administration for Immediate Release Consumer Media; 1998.888-Info- FDA. May 6, pp. 45. .
[30]
Ahuja, S. Impurities Evaluations of Pharmaceuticals; Dekker: New York, 1998.
[31]
Impurities in New Drug Product Q3B (R2); ICH Harmonised Tripartite Guidelines. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Current Step 4 Version, June 2,, 2006.
[32]
Kiran, S.S.M.; Rao, N.R.; Prasanthi, N.L. Pharmaceutical Impurities: An Overview; Indian. J. Pharm. Educ. Res., 2010, 44(3), 301-310.
[33]
Buhler, V. Vademecum for Vitamin Formulation; Stuttgart, Germany: Wiss. Verl-Ges, 1998.
[34]
Ayre, A. Impurity profiling of Pharmaceuticals. ARPB, 2011, 1(2), 76-90.
[35]
Ahuja, S.; Scypinski, S. Handbook of Modern Pharmaceutical Analysis; , 2011, p. Academic Press, NY. 298.
[36]
Ahuja, S. Chromatography of Pharmaceuticals: Natural Synthetic and Recombinant Products. ACS Symposium Series, 1992512. Am. Chem. Soc., Washington, DC. , p. 14.
[37]
Recombinant Products. ACS Symposium Series 512, Am. Chem. Soc., Washington, DC,, , p37.
[38]
Ahuja, S.; Jespersen, N. Modern Instrumental Analysis; , 2006, p. 47.
[39]
Dong, M.W. Modern HPLC for Practicing Scientists, 2006, 87-95.
[40]
Fong, S.; Li, Y. Capillary Electrophoresis: Principles, Practice, and Applications, Elsevier science publisher; 1992, pp. 1-11.
[41]
Lunn, G. Capillary Electrophoresis Methods for Pharmaceutical Analysis; New York, USA: Wiley, 1999.
[42]
Peter, J.S.; Ahmed, A.; Yan, W. An HPLC chromatographic reactor approach for investigating the hydrolytic stability of a pharmaceutical compound. J. Pharm. Biomed. Anal., 2006, 41(3), 883-890.
[43]
Radhakrishna, T.; Satynarayana, J.; Satynarayana, A. Determination of Loratidine and its related Impurities by HPLC. Indian Drugs, 2002, 39(6), 342.
[44]
Radhakrishna, T.; Satynarayana, J.; Satynarayana, A. HPLC method for the degradation of celecoxib and its related impurities. Indian Drugs, 2002, 40(3), 166.
[45]
Zawilla, N.H.; Li, B.; Hoogmartens, J.; Adams, E. Improved RP-LC method combined with pulsed electrochemical detection for the analysis of amikacin. J. Pharm. Biomed. Anal., 2006, 42, 114.
[46]
Shah, S.R.; Patel, M.A.; Naik, M.V.; Pradhan, P.K.; Upadhyay, U.M. Recent approches of impurity profiling in pharmaceutical analysis: A review. IJPSR, 2012, 3(10), 3603-3617.
[47]
Abha, D.; Avinash, K.; Ganesh, S.N.; Javed, A. Impurity profiling with use of hyphenated techniques. AJRC, 2012, 5(7), 875-881.
[48]
Anurag, J. Recent trends in impurity profiling of pharmaceutical products, MIT. Int. J. Pharma Sci., 2017, 3(1), 1-6.
[49]
Skrdla, P.J.; Abrahim, A.; Wu, Y. An HPLC chromatographic reactor approach for investigating the hydrolytic stability of a pharmaceutical compound. J. Pharm. Biomed. Anal., 2006, 41(3), 883-890.
[50]
Radhakrishna, T.; Satyanarayana, J.; Satyanarayan, A. A determination of loratidine and its related impurities by HPLC. Indian Drugs, 2002, 39(6), 342.
[51]
Nisha, M.; Ismail, M. Impurity profiling in bulk pharmaceutical batches using 19F NMR Spectroscopy and distinction between monomeric and dimeric impurities by NMR-based diffusion measurements. J. Pharm. Biomed. Anal., 1999, 19, 511.
[52]
International Conference on Harmonization, ICH Q3B (R2) Impurities in New Drug Substances, June 2006.
[53]
Prathap, B. A review on impurity profile in pharmaceutical substances. J. Pharm. Pharmaceuti. Sci, 2013, 2(3), 19-25.
[54]
Patil, P. Dr. Vaidya. Overview of impurity profiling. IJPRS, 2013, 2(2), 54-64.
[55]
J.A, Mollica.; S, Ahuja.; J, Cohen. Stability of pharmaceuticals. J. Pharm. Sci., 1978, 67(4), 443-465.
[56]
Zhang, T. Impurity; Structural identification/confirmation and profiling of Carbamazepine, U.S In: Pharmacopeia monograph for carbamazepine USP32–NF 27; , 1784.

Rights & Permissions Print Cite
Article Metrics
76
7
1
1
© 2024 Bentham Science Publishers | Privacy Policy