Author(s): Ashok B. Patel, Avadhi R. Bundheliya, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Arvind N. Lumbhani

Email(s): avadhibundheliya17@gmail.com

DOI: 10.52711/2231-5675.2021.00038   

Address: Dr. Ashok B. Patel1, Avadhi R. Bundheliya1*, Dr. Amitkumar J. Vyas1, Dr. Nilesh K. Patel1, Dr. Ajay I. Patel1, Dr. Arvind N. Lumbhani2
1Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dam, Bhavnagar Road, Rajkot - 360003 Gujarat, India.
2Gyanmanjari Pharmacy College, Survey No. 30, Sidsar Road, Near Iscon Eleven, Bhavnagr – 364001 Gujarat, India.
*Corresponding Author

Published In:   Volume - 11,      Issue - 3,     Year - 2021


ABSTRACT:
Sources of metal impurities can from anywhere in drug product as raw material which may produce using metal catalyst, excipients, process materials, Water or any solvent used, manufacturing equipment, environment, packaging materials. So, it leads to metal impurity in high amount present in final drug product that is why it is important to check the impurity level in final drug product or as well as in process also that it should be present in low or acceptable amount. Any Drug product is not completely pure, some amount of metal impurities are always present in pharmaceutical product may cause various toxicity when it will be administered. Thus it is necessary to check impurity level is present at acceptable amount. The present review gives an account of updated information about metal impurities and reviews the regulatory aspects for such metal impurities in drug substance/drug product. In addition the aim of this article is to discuss the currently used different analytical techniques for detection of metals from drug product like spectrophotometry, X – Ray florescence spectrometry, AAS, INAA, ICP – AES, ICP – MS, MP – AES, Laser Ablation – ICP – MS etc which is used for quality control of metal impurities in pharmaceuticals.


Cite this article:
Ashok B. Patel, Avadhi R. Bundheliya, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Arvind N. Lumbhani. A Review on Metal Impurities in Pharmaceuticals. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):212-2. doi: 10.52711/2231-5675.2021.00038

Cite(Electronic):
Ashok B. Patel, Avadhi R. Bundheliya, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Arvind N. Lumbhani. A Review on Metal Impurities in Pharmaceuticals. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):212-2. doi: 10.52711/2231-5675.2021.00038   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-3-8


REFERENCES:
1.    EMA – European Medicines Agency guidelines, “Impurities in New Drug substances Q3A(R2)”, CPMP, ICH, 2006.
2.    EMA – European Medicines Agency guidelines, “Impurities in New Drug products Q3B(R2)”, CPMP, ICH, 2006.
3.    N. Rama Rao, S. S. Mani Kiran and Prasanthi N. L. Pharmaceutical Impurities: An Overview. Indian Journal of Pharmaceutical Education and Research. 2010; 301 – 310.
4.    Maithani M et al. Elemental impurities in pharmaceutical products adding fuel to the fire.  Regulatory Toxicology and Pharmacology. 2019.
5.    Balaram V. Recent advances in the determination of elemental impurities in pharmaceuticals – Status, challenges and moving frontiers.  Trends in Analytical Chemistry.  2016; 83 – 95.
6.    Ab Latif WANI, Anjum ARA and Jawed Ahmed USMANI. Lead toxicity: a review.  Interdisciplinary Toxicology.  2015; 8: 55 – 64.
7.    Agency for Toxic Substances and Disease Registry, “Toxicological Profile for Vanadium”, U. S. Department of health and Human Services, Public Health Service, September 2012.
8.    Naser L. Rezk and Salma A. Rezk. Vanadium in therapy and toxicity mini – review and recommendation of further study. 2017.
9.    Air Quality Guidelines, 2nd Edn, WHO Regional office for Europe, Denmark, 2000.
10.    Shireen A et al. Lithium Toxicity. Stat Pearls. 2020.
11.    Drrell R et al. and USP Metal Impurities Advisory Panel. Metal Impurities in food and drugs. Pharmaceutical Journal.  2010; 27: 750 – 755.
12.    US Pharmacopoeia, NF 39, The United State Pharmacopoeials Convention Inc, Rockville, 2016, pp 268-271.
13.    US Pharmacopoeia, NF 39, The United State Pharmacopoeials Convention Inc, Rockville, 2016, pp 271-275
14.    Bhavna VM. Iron Determination – A Review of analytical methods. Asian J. Research Chem. 2011; 4 (3): 348-361.
15.    Milan H Ashutosh P and Champa Singh R. Heavy metal levels in selected leafy vegetables obtained from local market. Asian J. Research Chem. 2017; 10(3): 354-358.
16.    Mohammad R et al. Physicochemical and Heavy metal analysis of pond water. Asian J. Reaserch Chem. 2017; 10(1): 29-32.
17.     Somsubhra G et al. Inductively coupled plasma – Optical emission spectroscopy : A Review. Asian J. Pharm. Ana. 2013; 3(1): 24-33.
18.    Habeeb A et al. Pharmaceutical importance and significance of limit tests. Asian J. Pharm. 2017; 7(1): 30-34.  
19.    Bingbing L et al. Determination of gallium in fly ash by inductively coupled plasma atomic emission spectrometry. 2015; 27(3): 1093-1096.
20.    Mouli JBC et al. Estimation of metals in herbal leaves by ash extracts by using ICPOES and flame photometer. Asian J. Pharm. Ana. 2019; 9(2): 82-88.
21.    Dan X, Weichun Y, Qin L. Method development and validation for simultaneous determination of 44 Ca, 34S, 28Si and 18 othere trace elements in pharmaceutical packaging materials’ Extractable solutions by Inductively coupled plasma mass spectrophotometry (ICP-MS). Asian J. Pharm. Ana. 2020; 10(2): 51-66.

Recomonded Articles:

Author(s): K. Pramod, Shahid H. Ansari, Javed Ali

DOI:         Access: Open Access Read More

Author(s): Kirthi A, Shanmugam R, Mohana Lakshmi S , Ashok Kumar CK, Padmini K, Shanti Prathyusha M, Shilpa V

DOI:         Access: Open Access Read More

Author(s): G. Krishnamoorthy, C. Diana Priyadarshini, R. Senthamarai

DOI:         Access: Open Access Read More

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

Author(s): Mansi J. Chaudhari, Suraj R. Chaudhari, Shailesh S. Chalikwar, Atul A. Shirkhedkar

DOI: 10.5958/2231-5675.2018.00008.X         Access: Open Access Read More

Author(s): Khushboo Patel*, Dhara Patel, Jaya Dwivedi, Priyanka Newal, Dhananjay Meshram

DOI: 10.5958/2231-5675.2017.00039.4         Access: Open Access Read More

Author(s): B. Thangabalan, M. Salomi, N. Sunitha, S. Manohar Babu

DOI:         Access: Open Access Read More

Author(s): P. Janaki Pathi, N. Appala Raju, G.Parvathalu

DOI:         Access: Open Access Read More

Author(s): Paras Virani, Rajanit Sojitra, Hasumati Raj, Vineet Jain

DOI: 10.5958/2231-5675.2015.00025.3         Access: Open Access Read More

Author(s): Saroj Kumar Raul, Bukkuru Spandana, Patibandla Sameera, Vegiraju Vikitha

DOI:         Access: Open Access Read More

Author(s): S. Vidyadhara, RLC Sasidhar, B. Venkateswara Rao, P. Ratna Kumari

DOI:         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 

Popular Articles


Recent Articles




Tags