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REVIEW ARTICLE
Year : 2021  |  Volume : 36  |  Issue : 2  |  Page : 153-162

A comparative study of pharmacopoeial quality standards and regulations of radiopharmaceuticals


1 Microbiology Division Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
2 Department of Global Pharmacovigilance, Sun Pharmaceuticals Pvt. Ltd., Gurugram, Haryana, India
3 Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
4 Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India

Correspondence Address:
Dr. Prasad Thota
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijnm.ijnm_222_20

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Radiopharmaceutical preparations are the important pharmaceutical dosage forms used for the diagnosis and therapeutic purposes. Various pharmacopoeias are having methods for the quality control of these preparations in the form of monographs. Indian Pharmacopoeia (IP) also included these monographs in IP 2014 first time with the help of an experts' group on radiopharmaceutical, drawing expertise from elite stakeholder institutions and the core team of Indian Pharmacopoeia Commission. Since then, these standards are regularly updated through the IP addendum and bringing out new edition of IP. IP is a book of official methods as per Drugs and Cosmetic Act, 1940. These standards can be used in government laboratories, private laboratories, or academia in India and abroad. This review provides an overview of the journey of radiopharmaceuticals' standard setting in IP. A comprehensive comparative information of regulatory perspectives of radiopharmaceuticals in different jurisdictions such as the US, EU, and India is also presented.


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