Instrumental Methods for Pharmaceutical Trace Metals Analysis

Who Should Attend
This course is intended to help pharmaceutical professionals evaluate, select and employ spectrometric instruments for robust, unambiguous metals analyses. Metallic elements can occur as designed-in cationic or anionic components of the API, impurities, adulterants or as potential health hazards. Selecting an appropriate analytical method depends on the need for identification, concentration or location. Selection also includes the need for speed of analytical response and site compatibility. Personnel who will benefit from the course include:

  • Formulators
  • Quality program managers & analysts
  • Production managers
  • Scale-up pharmacists
  • CAPA and Root Cause Analysis personnel
  • Quality-by-Design (QbD) teams
  • In-process analysts
  • Product release analysts
  • Process-Analytical Technology (PAT) teams
  • Technology transfer personnel

Description
This 90-minute accredited online course course examines the presence and form of metals found in pharmaceutical drug products. Each condition calls for a distinct instrumental method in order to provide identification, concentration and in some cases, location of the metal of interest. The course addresses the physics underlying ICP-MS, LIBS, Atomic Absorption and Fluorescence, as well as wet methods. Following selection principles, the material includes guidelines for sampling, data reduction and interpretation.

Module 1:
  • Pharmaceutical trace metals in their various forms
  • Sensitivity and response groups for metal classes
  • Dispersion of metals in dosage forms
  • Spectrometric vs. chemical identification

Module 2:
  • Atomic absorption: simple, non structural, sensitive,
    wet reagents
  • LIBS: Simple, sensitive, structural response, no reagents
  • ICP-MS: Sensitive, relates to the molecular moiety, 
    sophisticated
  • Considering matrix and reagent effects

Module 3:
  • Reducing test data to information
  • Enhancing information with multivariate analysis
  • Relating results to the “big picture”
  • Method selection matrix

Question and Answer Session

John E. Carroll, C.Ph.C., President, Carroll Ventures, Inc., Managing Partner, Cadrai Technology Group

John E. Carroll is Managing Partner, Cadrai Technology Group and President, Carroll Ventures, Inc. The Cadrai Technology Group develops and presents focused training programs for issues germane to the current needs of the pharmaceutical industry including small-molecule, biologic and nutraceutical preparations. Cadrai has an equally strong focus in both training and business development for the analytical instrument industry. Among Cadrai successes are: ion-mobility spectrometry for cleaning verification, NIR dedicated to tablet & capsule analysis, laser-induced breakdown spectroscopy, chemical imaging and automated dissolution. As Pharmaceutical Business Unit Manager for Perstorp Analytical Instruments (now Foss), Mr. Carroll built a global, sustainable business that saw over 8,000 NIR test instruments placed within the pharmaceutical manufacturing industry. Mr. Carroll has a B.A.S in Engineering Technology/Chemistry, an M.B.A. (c) in International Marketing, sixty publications and numerous technical presentations. He is the author of “The NIR Desk Reference” (Carroll, He and Landa) and “The Handbook of FTIR” (Carroll). He is also the editor of “IR-MS: High sensitivity and selectivity for organic analysis” (Mattson and Carroll). Professional memberships include AAPS, ACS, CNIRS and ISPE.