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General Notices. <i>Japanese Pharmacopoeia<\/i>, 18th ed., Tokyo, pp. 1\u20134 (2021)."},{"key":"2","unstructured":"2) Ministry of Health, Labour and Welfare. 4.06 Sterility Test. <i>Japanese Pharmacopoeia<\/i>, 18th ed., Tokyo, pp. 144\u2013147 (2021)."},{"key":"3","unstructured":"3) Pharmacopoeial Discussion Group. \u201cSign-off Document Name: Test for Sterility\u201d (2002): &lt;https:\/\/www.pmda.go.jp\/files\/000232461.pdf&gt;, accessed 1 April, 2025."},{"key":"4","unstructured":"4) European Directorate for the Quality of Medicines &amp; HealthCare. \u201c2.6.1. Sterility\u201d 04\/2011 : 20601. <i>European Pharmacopoeia<\/i>, 11th ed., Strasbourg (2023)."},{"key":"5","unstructured":"5) United States Pharmacopeial Convention. \u232971\u232a Sterility Tests. <i>United States Pharmacopeia<\/i> (2022)."},{"key":"6","unstructured":"6) International Organization for Standardization. ISO 11737-2: 2019. \u201cSterilization of health care products\u2014microbiological methods. Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process\u201d (2019)."},{"key":"7","unstructured":"7) Ministry of Health, Labour and Welfare. Purified Sodium Hyaluronate Injection. Official Monographs. <i>Japanese Pharmacopoeia<\/i>, 18th ed., Tokyo, pp. 1710\u20131711 (2021)."},{"key":"8","unstructured":"8) United States Food and Drug Administration. \u201cIntent To Consider the Appropriate Classification of Hyaluronic Acid Intraarticular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence.\u201d <i>Federal Register<\/i>, <b>83<\/b>(242), 64844\u201364845, Docket No. FDA\u20132018\u2013N\u20134627 (2018)."},{"key":"9","unstructured":"9) Goto M, Hanyu T, Yoshio T, Matsuno H, Shimizu M, Murata N, Shiozawa S, Matsubara T, Yamana S, Matsuda T. Intra-articular injection of hyaluronate (SI-6601D) improves joint pain and synovial fluid prostaglandin E<sub>2<\/sub> levels in rheumatoid arthritis: a multicenter clinical trial. <i>Clin. Exp. Rheumatol.<\/i>, <b>19<\/b>, 377\u2013383 (2001)."},{"key":"10","doi-asserted-by":"crossref","unstructured":"10) Gotoh S, Miyazaki K, Onaya J, Sakamoto T, Tokuyasu K, Namiki O. Experimental knee pain model in rats and analgesic effect of sodium hyaluronate (SPH). <i>Nippon Yakurigaku Zasshi<\/i>, <b>92<\/b>, 17\u201327 (1988).","DOI":"10.1254\/fpj.92.17"},{"key":"11","doi-asserted-by":"crossref","unstructured":"11) Gotoh S, Onaya J, Abe M, Miyazaki K, Hamai A, Horie K, Tokuyasu K. Effects of the molecular weight of hyaluronic acid and its action mechanisms on experimental joint pain in rats. <i>Ann. Rheum. Dis.<\/i>, <b>52<\/b>, 817\u2013822 (1993).","DOI":"10.1136\/ard.52.11.817"},{"key":"12","doi-asserted-by":"crossref","unstructured":"12) Elmorsy S, Funakoshi T, Sasazawa F, Todoh M, Tadano S, Iwasaki N. Chondroprotective effects of high-molecular-weight cross-linked hyaluronic acid in a rabbit knee osteoarthritis model. <i>Osteoarthritis Cartilage<\/i>, <b>22<\/b>, 121\u2013127 (2014).","DOI":"10.1016\/j.joca.2013.10.005"},{"key":"13","doi-asserted-by":"crossref","unstructured":"13) Oren A, Garrity MG. List of new names and new combinations previously effectively, but not validly, published. <i>Int. J. Syst. Evol. Microbiol.<\/i>, <b>70<\/b>, 2960\u20132966 (2020).","DOI":"10.1099\/ijsem.0.004156"},{"key":"14","unstructured":"14) European Commission. \u201cEU GMP Annex 1: Manufacture of Sterile Medicinal Products\u201d (2022): &lt;https:\/\/www.gmp-compliance.org\/files\/guidemgr\/20220825_gmp-an1_en_0.pdf&gt;, accessed 1 April, 2025."},{"key":"15","unstructured":"15) The Microbiology Network. \u201cMethod Suitability Report, Membrane Filtration Sterility Test with QTMicro Apparatus, Hyaluronic Acid Sodium 10 mg\/mL\u201d (2015): &lt;https:\/\/www.qimedical.com\/wp-content\/uploads\/2015\/01\/CoA-MNI-2013-001-177.pdf&gt;, accessed 5 March, 2026."},{"key":"16","doi-asserted-by":"crossref","unstructured":"16) Ardizzoni A, Neglia RG, Baschieri MC, Cermelli C, Caratozzolo M, Righi E, Palmieri B, Blasi E. Influence of hyaluronic acid on bacterial and fungal species, including clinically relevant opportunistic pathogens. <i>J. Mater. Sci. Mater. Med.<\/i>, <b>22<\/b>, 2329\u20132338 (2011).","DOI":"10.1007\/s10856-011-4408-2"}],"container-title":["Biological and Pharmaceutical Bulletin"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/bpb\/49\/6\/49_b25-00818\/_pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,27]],"date-time":"2026-06-27T03:24:37Z","timestamp":1782530677000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/bpb\/49\/6\/49_b25-00818\/_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,23]]},"references-count":16,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026]]}},"URL":"https:\/\/doi.org\/10.1248\/bpb.b25-00818","relation":{},"ISSN":["0918-6158","1347-5215"],"issn-type":[{"value":"0918-6158","type":"print"},{"value":"1347-5215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,23]]},"article-number":"b25-00818"}}