{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T05:51:20Z","timestamp":1772603480368,"version":"3.50.1"},"reference-count":41,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T00:00:00Z","timestamp":1769558400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T00:00:00Z","timestamp":1769558400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2026,3]]},"DOI":"10.1007\/s43441-026-00916-0","type":"journal-article","created":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T16:18:05Z","timestamp":1769617085000},"page":"478-491","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Indian Pharmacopoeia Reference Standards: A Key Tool to Regulate the Quality of Pharmaceuticals"],"prefix":"10.1007","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2577-3830","authenticated-orcid":false,"given":"Arvind Kumar","family":"Sharma","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shruti","family":"Rastogi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Priyanka","family":"Nagar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suraj","family":"Tiwari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anuj Prakash","family":"Yadav","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robin","family":"Kumar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vivekanandan","family":"Kalaiselvan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2026,1,28]]},"reference":[{"key":"916_CR1","unstructured":"Working document QAS\/12.512\/Rev.1 [Internet]. Geneva: World Health Organization; 2013 [cited 2024 Jun 3]. Available from: https:\/\/cdn.who.int\/media\/docs\/default-source\/medicines\/pharmacopoeia\/review_qas13-512rev1_25032013.pdf?sfvrsn=d67325b9_3"},{"key":"916_CR2","unstructured":"Index of World Pharmacopoeias and Pharmacopoeial Authorities, Working document QAS\/11.453\/Rev.13 [Internet]. Geneva: Index of Pharmacopoeias, World Health Organization; 2013 Dec [cited 2024 May 24]. Available from: index-of-pharmacopoeias-2020c02a5de5c0b6405fba08b40f8e850b5a%20(1).pdf"},{"key":"916_CR3","unstructured":"International Organization for Standardization. ISO\/IEC Guide 99:2007 international vocabulary of basic and general terms in metrology [Internet]. 2007 [cited 2024 Mar 19]. Available from: https:\/\/www.iso.org\/obp\/ui\/en\/#iso:std:iso-iec:guide:99:ed-1:v2:en"},{"key":"916_CR4","unstructured":"Bunk DM. Reference materials and reference measurement procedures: an overview from a national metrology institute. PubMed. 2007 Nov 1, 28. PMCID: PMC2282405"},{"key":"916_CR5","first-page":"3","volume":"1012","author":"D Deuwer","year":"2004","unstructured":"Deuwer D, Parris R, White E, May V, Elbaum H. An approach to the metrologically sound traceable assessment of the chemical purity of organic reference materials. NIST Spec Publ. 2004;1012:3.","journal-title":"NIST Spec Publ"},{"key":"916_CR6","unstructured":"May WE, Parris RM, Beck CM, Fassett JD, Greenberg RR, Guenther FR, et al. Definitions of terms and modes used at NIST for value-assignment of reference materials for chemical measurements|NIST. 2000 Jan 1, 10."},{"key":"916_CR7","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1023\/A:1022374509064","volume":"58","author":"SLR Ellison","year":"2003","unstructured":"Ellison SLR, Rosslein M, Williams A. Quantifying uncertainty in analytical measurement. Eurachem\/CITAC Guide. J Anal Chem. 2003;58:191. https:\/\/doi.org\/10.1023\/A:1022374509064.","journal-title":"J Anal Chem"},{"key":"916_CR8","volume-title":"Indian pharmacopoeia","author":"Indian Pharmacopoeia Commission","year":"2022","unstructured":"Indian Pharmacopoeia Commission. Indian pharmacopoeia. 9th ed. Ghaziabad: Ministry of Health and Family Welfare, Government of India; 2022.","edition":"9"},{"key":"916_CR9","unstructured":"WHO. TRS 996 annex 1: good pharmacopoeial practices, WHO expert committee on specifications for pharmaceutical preparations: 50th report, 67\u201386. WHO; 2016."},{"key":"916_CR10","doi-asserted-by":"publisher","DOI":"10.1016\/s0149-6395(03)80008-9","volume-title":"Reference standards","author":"PA Culbert","year":"2004","unstructured":"Culbert PA, Johnson BD. Reference standards, vol. 5. Amsterdam: Elsevier; 2004. https:\/\/doi.org\/10.1016\/s0149-6395(03)80008-9."},{"issue":"12","key":"916_CR11","doi-asserted-by":"publisher","first-page":"101825","DOI":"10.1016\/j.jsps.2023.101825","volume":"31","author":"G Pratap","year":"2023","unstructured":"Pratap G, Rastogi S, Kumar A, Chauhan J, Sharma SK, Kumar M, et al. Ensuring the quality of medicines in India: an update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia. Saudi Pharm J. 2023;31(12):101825\u201335. https:\/\/doi.org\/10.1016\/j.jsps.2023.101825.","journal-title":"Saudi Pharm J"},{"key":"916_CR12","unstructured":"Ministry of Health and Family Welfare. Drugs and cosmetics act, 1940 and rules, 1945. [Internet]. Government of India; 2016 [cited 2024 Jan 13]. Available from: https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/acts_rules\/2016DrugsandCosmeticsAct1940Rules1945.pdf"},{"key":"916_CR13","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1201\/9781003296492-10","volume-title":"Regulations in India, global regulations of medicinal, pharmaceutical, and food products","author":"AK Sharma","year":"2024","unstructured":"Sharma AK. Regulations in India, global regulations of medicinal, pharmaceutical, and food products. 1st ed. London: CRC Press; 2024. p. 20. https:\/\/doi.org\/10.1201\/9781003296492-10.","edition":"1"},{"issue":"1","key":"916_CR14","doi-asserted-by":"publisher","first-page":"e280722207051","DOI":"10.2174\/2213240609666220728091253","volume":"9","author":"AK Sharma","year":"2022","unstructured":"Sharma AK, Ali F, Prakash A, Goyal RK. Impurities present in cardiovascular active substances and medicinal products: a pharmacopoeial perspective. Curr Chromatogr. 2022;9(1):e280722207051. https:\/\/doi.org\/10.2174\/2213240609666220728091253.","journal-title":"Curr Chromatogr"},{"issue":"2","key":"916_CR15","doi-asserted-by":"publisher","first-page":"352","DOI":"10.1208\/s12248-014-9566-y","volume":"16","author":"JF Bower","year":"2014","unstructured":"Bower JF, McClung JB, Watson C, Osumi T, Pastre K. Recommendations and best practices for reference standards and reagents used in bioanalytical method validation. AAPS J. 2014;16(2):352\u20136. https:\/\/doi.org\/10.1208\/s12248-014-9566-y.","journal-title":"AAPS J"},{"key":"916_CR16","unstructured":"Indian Pharmacopoeia Commission. Guidance document, Indian pharmacopoeia reference substances [Internet]. vol. 1.0. Ghaziabad: Indian Pharmacopoeia Commission; 2022 [cited 2023 Mar 17]. Available from: https:\/\/ipc.gov.in\/images\/GD-09-IP_Reference_Substances.pdf"},{"key":"916_CR17","unstructured":"IPC Notices and Updates. https:\/\/ipc.gov.in\/news-highlights\/1091-ipc-notices-and-updates.html. Accessed 05 Dec 2025"},{"key":"916_CR18","unstructured":"Dr Bart Blanchaert. Ph. Eur. Reference standards: establishment and use. The European directorate for the quality of medicines & healthcare (EDQM); 2023 Jun 30."},{"key":"916_CR19","unstructured":"International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q6a: specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances [Internet]. 1999 [cited 2024 Mar 19]. Available from: https:\/\/www.ich.org\/page\/quality-guidelines"},{"key":"916_CR20","doi-asserted-by":"publisher","first-page":"451","DOI":"10.1007\/978-981-15-5534-3_16","volume-title":"Drug discovery and development","author":"K Bangarurajan","year":"2021","unstructured":"Bangarurajan K. Regulatory process for new drug approval in India. In: Drug discovery and development. Cham: Springer; 2021. p. 451\u201363. https:\/\/doi.org\/10.1007\/978-981-15-5534-3_16."},{"key":"916_CR21","unstructured":"WHO. Annex 2 WHO manual for the preparation of reference materials for use as secondary standards in antibody testing [Internet]. 2022 [cited 2024 Apr 3]. Available from: https:\/\/cdn.who.int\/media\/docs\/default-source\/biologicals\/annex-2---who-guidelines-on-secondary-standards-for-antibody-testing---11-may-2022.pdf?sfvrsn=c0d1c8ce_1&download=true"},{"issue":"11","key":"916_CR22","doi-asserted-by":"publisher","first-page":"776","DOI":"10.1007\/s11094-016-1369-2","volume":"49","author":"VA Merkulov","year":"2016","unstructured":"Merkulov VA, Sakanyan EI, Klimov VI, Shemeryankina TB, Yashkir VA, Barmin AV. Modern approaches to the development of reference standards for quality assessment of drug substances. Pharm Chem J. 2016;49(11):776\u20138. https:\/\/doi.org\/10.1007\/s11094-016-1369-2.","journal-title":"Pharm Chem J"},{"key":"916_CR23","unstructured":"Lodi A. Intended use of reference standards: key role of compendial RS in quality measurements #1 reference standards are part of analytical procedures [Internet]. 2019 [cited 2024 Mar 17]. Available from: https:\/\/www.edqm.eu\/documents\/52006\/248787\/presentation-rs-symposium-irss-session1-compendial-reference-standards-march2019.pdf\/6641f2b6-9e6a-4d7a-d3ad-cf3d87ce4ba1?t=1637178270240"},{"key":"916_CR24","unstructured":"Indian Pharmacopoeia Commission. Home\u2013Indian pharmacopoeia commission [Internet]. Ipc.gov.in. [cited 2023 Nov 29]. Available from: https:\/\/ipc.gov.in\/"},{"issue":"1","key":"916_CR25","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1016\/j.jpba.2005.07.017","volume":"40","author":"RL Williams","year":"2006","unstructured":"Williams RL. Official USP reference standards: metrology concepts, overview, and scientific issues and opportunities. J Pharm Biomed Anal. 2006;40(1):3\u201315. https:\/\/doi.org\/10.1016\/j.jpba.2005.07.017.","journal-title":"J Pharm Biomed Anal"},{"key":"916_CR26","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1201\/9781032697444-1","volume-title":"Regulatory aspects of quality control in pharmaceuticals","author":"S Rastogi","year":"2024","unstructured":"Rastogi S, Pratap G. Regulatory aspects of quality control in pharmaceuticals. London: CRC Press; 2024. p. 1\u201314. https:\/\/doi.org\/10.1201\/9781032697444-1."},{"issue":"3\u20134","key":"916_CR27","doi-asserted-by":"publisher","first-page":"388","DOI":"10.1007\/s002160050719","volume":"360","author":"A Boenke","year":"1998","unstructured":"Boenke A. Pure substances and a new generation of CRMs for chemical industry. Fresenius J Anal Chem. 1998;360(3\u20134):388\u201392. https:\/\/doi.org\/10.1007\/s002160050719.","journal-title":"Fresenius J Anal Chem"},{"key":"916_CR28","unstructured":"ISO 17034. General requirements for the competence of reference material producers. Geneva: International Organization for Standardization (ISO), 1st edn Reference number ISO 17034:2016 (E)"},{"key":"916_CR29","unstructured":"WHO. ICH TRS943 annex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances. Geneva: World Health Organization; 2007."},{"issue":"1","key":"916_CR30","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1007\/s007690000261","volume":"6","author":"TPJ Linsinger","year":"2001","unstructured":"Linsinger TPJ, van Schimmel H, Lamberty A. Homogeneity and stability of reference materials. Accredit Qual Assur. 2001;6(1):20\u20135. https:\/\/doi.org\/10.1007\/s007690000261.","journal-title":"Accredit Qual Assur"},{"issue":"2\u20133","key":"916_CR31","doi-asserted-by":"publisher","first-page":"183","DOI":"10.1007\/s002160100719","volume":"370","author":"TPJ Linsinger","year":"2001","unstructured":"Linsinger TPJ, Pauwels J, Lamberty A, Schimmel HG, Der V, Siekmann L. Estimating the uncertainty of stability for matrix CRMs. Fresenius J Anal Chem. 2001;370(2\u20133):183\u20138. https:\/\/doi.org\/10.1007\/s002160100719.","journal-title":"Fresenius J Anal Chem"},{"key":"916_CR32","first-page":"49","volume":"33","author":"I Farrance","year":"2012","unstructured":"Farrance I, Frenkel R. Uncertainty of measurement: a review of the rules for calculating uncertainty components through functional relationships. Clin Biochem Rev. 2012;33:49.","journal-title":"Clin Biochem Rev"},{"key":"916_CR33","unstructured":"JCGM. Evaluation of measurement data\u2013guide to the expression of uncertainty in measurement \u00c9valuation des donn\u00e9es de mesure\u2013guide pour l\u2019expression de l\u2019incertitude de mesure. 2008 Sep."},{"key":"916_CR34","volume-title":"Guide 31 reference materials\u2013contents of certificates and labels","author":"ISO","year":"1998","unstructured":"ISO. Guide 31 reference materials\u2013contents of certificates and labels. Geneva: International Organization for Standardization ISO; 1998."},{"key":"916_CR35","volume-title":"Guide 34 general requirements for the competence of reference material producers","author":"ISO","year":"1999","unstructured":"ISO. Guide 34 general requirements for the competence of reference material producers. Geneva: International Organization for Standardization ISO; 1999."},{"key":"916_CR36","volume-title":"General requirements for the competence of testing and calibration laboratories","author":"ISO\/IEC 17025","year":"2005","unstructured":"ISO\/IEC 17025. General requirements for the competence of testing and calibration laboratories. Geneva: International Organization for Standardization ISO; 2005."},{"key":"916_CR37","unstructured":"ISO. ISO\/guide 35:2017(en) reference materials\u2014guidance for characterization and assessment of homogeneity and stability [Internet]. Iso.org. ISO; 2023 [cited 2024 Apr 3]. Available from: https:\/\/www.iso.org\/obp\/ui\/en\/#iso:std:iso:guide:35:ed-4:v1:en"},{"issue":"6","key":"916_CR38","doi-asserted-by":"publisher","first-page":"1317","DOI":"10.1007\/s11095-023-03493-1","volume":"40","author":"D McCarthy","year":"2023","unstructured":"McCarthy D, Han Y, Carrick K, Schmidt DR, Workman WE, Matejtschuk P, et al. Reference standards to support quality of synthetic peptide therapeutics. Pharm Res. 2023;40(6):1317\u201328. https:\/\/doi.org\/10.1007\/s11095-023-03493-1.","journal-title":"Pharm Res"},{"issue":"10","key":"916_CR39","doi-asserted-by":"publisher","first-page":"1725","DOI":"10.1023\/B:PHAM.0000045222.01170.4c","volume":"21","author":"L Bhattacharyya","year":"2004","unstructured":"Bhattacharyya L, Cecil T, Dabbah R, Roll D, Schuber S, Sheinin EB, et al. The value of USP public standards for therapeutic products. Pharm Res. 2004;21(10):1725\u201331. https:\/\/doi.org\/10.1023\/B:PHAM.0000045222.01170.4c.","journal-title":"Pharm Res"},{"key":"916_CR40","doi-asserted-by":"publisher","first-page":"1203","DOI":"10.1007\/s11095-010-0118-6","volume":"27","author":"WF Koch","year":"2010","unstructured":"Koch WF, Hauck WW, de Mars SS, Williams RL. Measurement science for food and drug monographs: toward a global system. Pharm Res. 2010;27:1203\u20137. https:\/\/doi.org\/10.1007\/s11095-010-0118-6.","journal-title":"Pharm Res"},{"issue":"3","key":"916_CR41","doi-asserted-by":"publisher","first-page":"101985","DOI":"10.1016\/j.jsps.2024.101985","volume":"32","author":"AK Sharma","year":"2024","unstructured":"Sharma AK, Rastogi S, Ali F, Yadav AP, Goyal RK. A comprehensive quality control and cost comparison study of branded and generic angiotensin receptor blockers. Saudi Pharm J. 2024;32(3):101985. https:\/\/doi.org\/10.1016\/j.jsps.2024.101985.","journal-title":"Saudi Pharm J"}],"container-title":["Therapeutic Innovation & Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00916-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-026-00916-0","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00916-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T14:49:35Z","timestamp":1772117375000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-026-00916-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,28]]},"references-count":41,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["916"],"URL":"https:\/\/doi.org\/10.1007\/s43441-026-00916-0","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,28]]},"assertion":[{"value":"1 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 January 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 January 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}