{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:57:03Z","timestamp":1787500623567,"version":"build-2736575974"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,10,22]],"date-time":"2020-10-22T00:00:00Z","timestamp":1603324800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp; Perspec"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Benzathine penicillin G (BPG) is used as first\u2010line treatment for most forms of syphilis and as secondary prophylaxis against rheumatic heart disease (RHD). Perceptions that poor quality of BPG is linked to reported adverse effects and therapeutic failure may impact syphilis and RHD control programs. Clinical networks and web\u2010based advertising were used to obtain vials of BPG from a wide range of countries. The quality of BPG was assessed using a high performance liquid chromatography assay capable of detecting relevant impurities and degradation products. Tests for water content, presence of heavy metals and physical characteristics of BPG, including particle size analysis and optical microscopy, also were conducted. Thirty\u2010five batches of BPG were sourced from 16 countries across 4 WHO regions. All batches passed the US Pharmacopeia requirements for BPG injection (content), with no evidence of breakdown products or other detected contaminants. Water content and heavy metal analysis (n\u00a0=\u00a011) indicated adherence to regulatory standards and Good Manufacturing Practice. Particle size analysis (n\u00a0=\u00a020) found two batches with aggregated particles (&gt;400\u00a0\u00b5m) that were dispersed following sonication. Current batches of BPG were of satisfactory pharmaceutical quality but aggregated particles were found in a modest proportion of samples. Future studies should focus on the physical characteristics of BPG which may contribute to variations in plasma penicillin concentrations an observed needle blockages in clinical practice. Pharmacopeial monographs could be revised to include standards on particle size and crystal morphology of BPG.<\/jats:p>","DOI":"10.1002\/prp2.668","type":"journal-article","created":{"date-parts":[[2020,10,22]],"date-time":"2020-10-22T13:01:06Z","timestamp":1603371666000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Quality of benzathine penicillin G: A multinational cross\u2010sectional study"],"prefix":"10.1002","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6448-4559","authenticated-orcid":false,"given":"Robert M.","family":"Hand","sequence":"first","affiliation":[{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9971-9290","authenticated-orcid":false,"given":"S. M. D. K. Ganga","family":"Senarathna","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Biomedical Sciences Curtin University Bentley Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2599-5289","authenticated-orcid":false,"given":"Madhu","family":"Page\u2010Sharp","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Biomedical Sciences Curtin University Bentley Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4110-9283","authenticated-orcid":false,"given":"Katherine","family":"Gray","sequence":"additional","affiliation":[{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1930-1551","authenticated-orcid":false,"given":"Dianne","family":"Sika\u2010Paotonu","sequence":"additional","affiliation":[{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"},{"name":"Dean\u2019s Department and Department of Pathology &amp; Molecular Medicine Wellington School of Medicine and Health Sciences University of Otago Dunedin New Zealand"},{"name":"Faculty of Health Victoria University of Wellington Wellington New Zealand"},{"name":"Maurice Wilkins Centre for Molecular Biodiscovery University of Auckland Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5453-070X","authenticated-orcid":false,"given":"Meru","family":"Sheel","sequence":"additional","affiliation":[{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2141-630X","authenticated-orcid":false,"given":"Victor T. G.","family":"Chuang","sequence":"additional","affiliation":[{"name":"School of Pharmacy Monash University Malaysia Selangor Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6007-033X","authenticated-orcid":false,"given":"Jorge","family":"Martinez","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Biomedical Sciences Curtin University Bentley Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9719-7123","authenticated-orcid":false,"given":"Giuseppe","family":"Luna","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Biomedical Sciences Curtin University Bentley Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4334-5351","authenticated-orcid":false,"given":"Laurens","family":"Manning","sequence":"additional","affiliation":[{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"},{"name":"Faculty of Health and Medical Sciences University of Western Australia Perth Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosemary","family":"Wyber","sequence":"additional","affiliation":[{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"},{"name":"The George Institute for Global Health Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1182-9792","authenticated-orcid":false,"given":"Jonathan R.","family":"Carapetis","sequence":"additional","affiliation":[{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"},{"name":"Department of Infectious Diseases Perth Children\u2019s Hospital Perth Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3850-1778","authenticated-orcid":false,"given":"Kevin T.","family":"Batty","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Biomedical Sciences Curtin University Bentley Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,10,22]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM195702212560803"},{"issue":"6","key":"e_1_2_12_3_1","doi-asserted-by":"crossref","first-page":"960","DOI":"10.1542\/peds.97.6.960","article-title":"A review of the rationale and advantages of various mixtures of benzathine penicillin G","volume":"97","author":"Bass JW","year":"1996","journal-title":"Pediatrics"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.13259"},{"key":"e_1_2_12_5_1","unstructured":"World Health Organization.World Health Organization Model List of Essential Medicines 21st List. edn. 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