Allowable levels of excipients in drug products

References

1. CFR – Code of Federal Regulations Title 21, CFR 210.3(b)(8). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.3. Accessed on 09 July 2019.
2. Elder DP, Kuentz M, Holm R. Pharmaceutical excipients — quality, regulatory and biopharmaceutical considerations. Eur J Pharm Sci, 87, 2016, 88-99.
3. Rowe R, et al. Handbook of Pharmaceutical Ingredients, 7^th Edition, Pharmaceutical Press, London, 2012.
4. Aulton ME. Pharmaceutics: The science of dosage form design, Churchill Livingstone Press, London, First Edition, Reprinted 2000.
5. Florence AT, Attwood D. Physicochemical Principles of Pharmacy, Pharmaceutical Press, London, Third Edition, 1998, Reprinted 2004.
6. FDA Inactive Ingredient Search for Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm. Accessed on 09 July 2019.
7. IPEC-Americas Publishes Position Paper on FDA Inactive Ingredient Database. Wednesday, April 22, 2015. https://ipecamericas.org/news/ipec-americas-publishes-position-paper-fda-inactive-ingredient-database. Accessed on 09 July 2019.
8. Most Recent Changes to the IID Database. 05/06/2019. https://www.fda.gov/drugs/drug-approvals-and-databases/most-recent-changes-iid-database. Accessed on 09 July 2019.
9. Kozarewicz P, Loftsson T. “Novel excipients – regulatory challenges and perspectives – the EU insight” Int J Pharm, Volume 546, Issues 1–2, 30 July 2018, 176-179