Reference Center


Following is a list publications by IPEC members on topics related to excipients. If you are a member of IPEC and would like to submit a reference to an excipient article you have written, please email us with your information.

2013 Schoneker, D.R. (2013). Increasing Focus on Excipient Quality Worldwide – Total Excipient Control (TEC) – A Pathway to Increased Patient Safety. Pharma Times, 45(3), 54-56.
  Erskine, B. (2013). Standardizing Excipient Information to Achieve Supply-Chain Security. Pharmaceutical Technology, 18-21.
  Clark, J.E., Punzi, J.S. (2013). Modernization of the Standards for Elemental Impurities. Pharmaceutical Technology, 37(2).
  Garofalo, J., Klug, D.B., Schoneker, D.R. (2013). Conforming to the IPEC CoA Guide. Pharmaceutical Technology, 37(3), 28-31.
2012 Silverstein, I.B. (2012). The American National Standard for Excipient GMP. Pharmaceutical Technology, 36(3), 38-41.
  Carter, D.W. (2012). Standardized Excipient GMP.Pharmaceutical Technology, 36(3), 42-46.
2011 Garofalo, J. (2011) IPEC Contributions Mitigate Risk in Excipient Supply Chain. PDA Letter, May, 32-33.
  Silverstein, I.B.(2011).IPEC–Americas Releases Good Distribution Practices Audit Guide. Pharmaceutical Technology
  Carter, D.W. (2011). Risk Assessment for Excipients for Enhanced Patient Safety. Pharmaceutical Technology-Solid Dosage & Excipients, s29-s33.
  Schoneker, D.R. (2011) Total Excipient Control: A Pathway to Increased Patient Safety. Pharmaceutical Technology-Solid Dosage & Excipients
2010 Silverstein, I.B.(2010).Why is GMP Training a Necessity at Excipient Sites? American Pharmaceutical Review, 13(5).
  Silverstein, I.B.(2010). Excipient Pedigree Verification. Pharmaceutical Technology CPhI/ICSE, S28.
  Silverstein, I.B.(2010). IPEA Excipient GMP Certifcation Program. Pharmaceutical Technology Sterile Manufacturing
  Carter, D.W.(2010). Excipient Quality Agreements, Exploring the IPEC Quality Agreement Guide and Template. Contract Pharma, Sept., 4-13.
  Falk, A. (2010). Excipient Pedigree as a Supply Chain Tool. Pharmaceutical Technology
2009 Block, L.H., Moreton, R.C, Apte, S.P., Wendt, R.H., Munson, E.J., Creekmore, J.R., Persaud, I.V., Sheehan, C. and Wang, H.(2009). Co-Processed Excipients. Pharmacopeial Forum. [Online] (2009), 35, (4), July and Aug., 1026-1028.
  Guazzaroni-Jacobs, M., Klug, D.B., Moreton, R.C. and Silverstein, I.B., Chimica Oggi. (2009). Qualification of Excipients for use in Pharmaceuticals. Chemistry Today. September/October, 6-8.
  Moreton, R.C. (2009). Commonly used Excipients in Pharmaceutical Suspensions, Pharmaceutical Suspensions: From Formulation Development to Manufacturing (67-102). Kulshreshtha, A.K., Singh, O.N. and Wall, G.M. (Eds.), New York, NY: Springer. 
  Moreton, R.C. (2009). Part 1: "Functionality and Performance of Excipients in a Quality-by-Design World". American Pharmaceutical Review, 12, (1), 40-44.
  Moreton, R.C. (2009). Part 2: "Functionality and Performance of Excipients in a Quality-by-Design World: Excipient Variability, QbD and Robust Formulations". American Pharmaceutical Review, 12, (2), 24 and 27.
  Moreton, R.C. (2009). Part 3: "Functionality and Performance of Excipients in a Quality-by-Design World". American Pharmaceutical Review, 12, (4), 22-26.
  Moreton, R.C. (2009). Part 4: "Functionality and Performance of Excipients in a Quality-by-Design World: Obtaining Information on Excipient Variability for Formulation Design Space". American Pharmaceutical Review, 12 (5), 28-33.
  Moreton, R.C. (2009). Part 5: "Functionality and Performance of Excipients in a Quality-by-Design World: Changes in the Sourcing and Supply of Pharmaceutical Excipients". American Pharmaceutical Review, 12 (6) 12-17.
  Silverstein, I.B. The Case for Supplier Qualification. Pharmaceutical Technology.October 2009.
  Silverstein, I.B., Merrell, P. Evaluating Excipient Stability. Pharmaceutical Technology.September 2009.
  Guazzaroni-Jacobs, M., Klug, D.B., Moreton, R.C. and Silverstein, I.B., Qualification of Excipients for use in Pharmaceuticals. Chimica Oggi (Chemistry Today), (2009), 27, (5), September/October, 6-8.
  Guazzaroni-Jacobs, M., Klug, D.B., Moreton, R.C. and Silverstein, I.B. (2009).Eye on Excipients. Tablets & Capsules, 6, (4), 45-50
 2008 Steele, D,F., Moreton, R.C., Staniforth, J.N., Young, P.M., Tobyn, M.J., and Edge, S., (2008). Surface Energy of Microcrystalline Cellulose Determined by Capillary Intrusion and Inverse Gas Chromatography. AAPS Journal, 10, (3), 494-503.
  Carter, D.W., Falk, A., Guazzaroni-Jacobs, M.,Schoneker, D., Silverstein, I.B. Excipient-Control Strategies. Pharmaceutical Technology.2008.
  Guazzaroni-Jacobs, Moreton, R.C.and Silverstein, I.B. Eye on Excipients. Tablets & Capsules, May 2008.
  Silverstein, I.B. Inside IPEC-Americas:Excipient Audits and API Audits are Worlds Apart. Pharmaceutical Technology. May 2008.
  Silverstein, I.B. The Case for Excipient GMPs. American Pharmaceutical Outsourcing. March/April 2008.
 2007 Amidon, G.E., Peck, G.E., Block, L.H., Moreton, R.C., Katdare, A., Lafaver, R., and Sheehan, C., Proposed New USP General Information Chapter, Excipient Performance <1059>. Pharm. Forum, (2007), 33, (6), 1311-1323.
  Silverstein, I.B. Bulk Phrmaceutical Excipient GMPs. Good Manufacturing Practices for Pharmaceuticals, 6th Edition, 2007
  Klug, D., Van Meter, A., and Horne, L. The Excipient Information Package, A Win-Win Solution: The EIP process addresses the problems encountered with numerous questionnaires when qualifying excipient manufacturers.  Pharmaceutical Technology. Nov. 2007.
 2006 Moreton, R.C., Excipient Interactions, in Excipient Development for Pharmaceutical, Biotechnology and Drug Delivery Systems, Katdare, A.V. and Chaubal, M.V. (Eds.), Informa Healthcare, New York, 2006, 93 - 108. 
  Moreton, R.C., Functionality and Performance of Excipients, Pharmaceutical Technology. (2006) 30, (10 - Suppl), s4-s14. 
  Silverstein, I.B. China's Proposed New License Requirements for the Use of Imported Excipients. American Pharmaceutical Outsourcing, July/August 2006.
 2005 Silverstein, I.B. (2005). Excipient GMP Auditing-A Risk Based Approach. American Pharmaceutical Review, September/October 2005.
 2004 Silverstein, I.B. (2004). How IPEA’s Auditing Program Can Help Both Producers and Users. American Pharmaceutical Review, May/June 2004.
  Silverstein, I.B. (2004). Excipient Auditing: Auditing Excipient Suppliers: Advantage for Producers. Tablets & Capsules, July 2004.
 2003 Steele, D.F., Edge, S., Tobyn, M.J., Moreton, R.C. and Staniforth, J.N. Adsorption of an Amine Drug onto Microcrystalline Cellulose and Silicified Microcrystalline Cellulose Samples. Drug Dev. Ind. Pharm., (2003), 29, (4), 475 - 487.
 2002 Silverstein, I.B. Excipient GMP Quality Standards, One is Enough. Pharmaceutical Technology, June 2002.
 2001 Silverstein, I.B.Qualification of Excipient Vendors.The Journal of Pharmaceutical & Biopharmaceutical Contract Manufacturing and Packaging, September/October 2001.
 1999 Moreton, R.C., Aspects relating to Excipient Quality and Specifications. Pharm. Technol. Europe, (1999) 11, (12), 26 - 29.
 1998 Moreton, R.C., New Excipients - From Idea to Market? American Pharmaceutical Review, (1998), 1, (1) 6 - 12.
  Silverstein, I.B. Polymeric Pharmaceutical Excipients. Pharmaceutical Dosage Forms: Disperse Systems, 1998.
 1997 Silverstein, I.B. Facility, Equipment, and Process Changes, Good Manufacturing Practices for Bulk Pharmaceutical Chemicals: Validation and other Regulatory Issues, 1997.
 1994 Wotton, P.K., Wade, G. and Moreton R.C., Excipients, in International Pharmaceutical Product Registration - Aspects of Quality, Safety and Efficacy, Cartwright, A.C. and Matthews, B.R. (Eds.), Ellis Horwood, London, UK, (1994), Chapter 5, 148 - 171.