Page 32 - ARNM-2-3
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Advances in Radiotherapy
            & Nuclear Medicine                                                   QC parameters in radiopharmaceuticals



            15.  Radiopharmaceutical Preparations, Japanese Pharmacopoeia.   29.  Sterility, The International Pharmacopoeia. 11  ed. Geneva:
                                                                                                   th
               18  ed.; 2021.                                     World Health Organization; 2023.
                 th
            16.  Khurshid  SJ,  Sadiq  MZ.  Quality  assurance  in  30.  Sterility Testing of Radiopharmaceuticals. Available from:
               nuclear  medicine--biological  quality  control  of  https://www.cup-freitag.de/en/radioster/sterile-testing-of-
               radiopharmaceuticals. Pak J Pharm Sci. 1996;9(1):43-54.  radiopharmaceuticals [Last accessed on 2023 Nov 20].
            17.  Maltby P, Liverpool (UK). Radiopharmacy Quality Control.   31.  Indian   Pharmacopoeia.   Approach  to  Alternative
               Available  from:  https://www.eanm.org/content-eanm/  Microbiological Methods. 9  ed. Ghaziabad: Indian
                                                                                        th
               uploads/cte-archive/2009/cte-6/cte6_3.pdf [Last accessed   Pharmacopoeia Commission; 2022.
               on 2023 Nov 20].
                                                               32.  Alternative Methods for Control of Microbiological Quality,
            18.  Radiopharmaceuticals: Directives 65/65/EEC, 75/318/EEC as   British Pharmacopeia; 2023.
               amended, Directive 89/343/EEC; 1990.
                                                               33.  Validation of Alternative Microbiological Methods,  United
            19.  Radiopharmaceuticals: Directives 65/65/EEC, 75/318/EEC as   States Pharmacopeia. Rockville, MD: The United States
               amended, Directive89/343/EEC; 1990.                Pharmacopoeial Convention; 2022.
            20.  The International Pharmacopoeia.  Radiopharmaceuticals   34.  Arjun C, Karkhanis B, Korde AG. Bacterial  Endotoxin
               General Monograph, Working Document QAS/13.542/Rev.2;   Testing of Injectable Radiopharmaceuticals: BRIT Experience.
               2017. Available from: https://www.who.int/docs/default-  Austria: International Atomic Energy Agency (IAEA);
               source/medicines/norms-and-standards/current-projects/  2020. Available from: https://inis.iaea.org/search/search.
               qas13-542rev2-general-chapter-radiopharmaceuticals.  aspx?orig_q=RN:52009402 [Last accessed on 2023 Nov 20].
               pdf?sfvrsn=516dbf81_2 [Last accessed on 2023 Nov 20].
                                                               35.  Bacterial Endotoxin,  Indian Pharmacopoeia. 9  ed.
                                                                                                         th
            21.  Loveless   VS.   Quality  Control  of  Compounded  Ghaziabad: Indian Pharmacopoeia Commission; 2022.
               Radiopharmaceuticals. Vol. 15., Lesson 3. United States:
               UNM College of Pharmacy; 2009.                  36.  Bacterial Endotoxin, British Pharmacopeia; 2023.
                                                               37.  Bacterial Endotoxin, United States Pharmacopeia. Rockville,
            22.  Gillings N, Hjelstuen O, Ballinger J,  et al. Guideline
               on current good radiopharmacy practice (cGRPP) for   MD: The United States Pharmacopoeial Convention; 2022.
                                                                                                            th
               the small-scale preparation of radiopharmaceuticals.   38.  Bacterial Endotoxin, The International Pharmacopoeia. 11
               EJNMMI      Radiopharm     Chem.     2021;6:8.     ed. Geneva: World Health Organization; 2023.
               doi: 10.1186/s41181-021-00123-2
                                                               39.  Importance  of  the  LAL  Assay  for  Testing
            23.  Saha GB. Quality control of radiopharmaceuticals. In:   Radiopharmaceuticals. Radiopharmaceuticals in Modern
               Fundamentals of Nuclear Pharmacy. New York: Springer; 1998.   Medicine. Available from: https://www.wakopyrostar.com/
               doi: 10.1007/978-1-4757-2934-4_8                   blog/kit-lal/post/importance-of-the-lal-assay-for-testing-
                                                                  radiopharmaceuticals [Last accessed on 2023 Nov 20].
            24.  Wind  K. The  sterility testing of  radiopharmaceuticals.
               In:  Radiopharmacy and Radiopharmacology Yearbook;   40.  Rabbit Pyrogen Test, Indian Pharmacopoeia. 9  ed.
                                                                                                         th
               1985. Available from: https://www.taylorfrancis.com/  Ghaziabad: Indian Pharmacopoeia Commission; 2022.
               chapters/edit/10.4324/9781315074771-2/sterility-testing-  41.  Methods  of  Preparation  of  Sterile  products,  British
               radiopharmaceuticals-kevin-wind [Last  accessed  on  2023   Pharmacopeia; 2023.
               Nov 20].
                                                               42.  GMP Guidelines Uncategorized. Parametric Release by API
            25.  Sharma S, Jain S, Baldi A, Singh RK, Sharma RK.   FIRST0. Available from: https://www.apifirst.in/2020/12/08/
               Intricacies in the approval ofradiopharmaceuticals -   parametric-release [Last accessed on 2020 Dec 08].
               regulatory perspectives and the way forward.  Curr Sci.
               2019;116(1):47-55.                              43.  Sharma S, Rajan MG, Baldi A, Singh RK, Sharma RK. The
                                                                  regulatory dilemma for import of radiopharmaceuticals in
               doi: 10.18520/cs/v116/i1/47-55
                                                                  India. Curr Sci. 2019;116:1787-1789.
            26.  Sterility,  Indian Pharmacopoeia. 9  ed. Ghaziabad: Indian   44.  European  Medicines  Agency.  Veterinary Medicines and
                                        th
               Pharmacopoeia Commission; 2022.
                                                                  Inspections.  In: Guideline on Parametric Release:  EMEA/
            27.  Sterility,  British  Pharmacopeia. Ghaziabad: Indian   CVMP/QWP/339588/2005-Consultation.  London:
               Pharmacopoeia Commission; 2023.                    Committee for Medicinal Products for Veterinary Use; 2006.
            28.  Sterility,  United States Pharmacopeia.  Rockville, MD: The   45.  Parametric Release and Real-Time Release Testing.
               United States Pharmacopoeial Convention; 2022.     Pharmaceutical Technology; 2012.








            Volume 2 Issue 3 (2024)                         12                             doi: 10.36922/arnm.3619
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