Jordi’s inorganic chemists have specific expertise in elemental analysis and work with the latest instrumentation. We provide quick turnaround for method development, validation and analysis.
USP 232/233/2232
- FDA mandated as of January 2018
- Defines acceptable limits for elemental impurities in drug products (and vitamins)
- Establishes Permitted Daily Exposures (PDEs) for 24 elements
- Manufacturers approved under an NDA must submit results directly to FDA
- Manufacturers of drug products not approved under an NDA must have documentation on file ready for inspection.
ICH Q3D
- Establishes Permitted Daily Exposures (PDEs) for 24 elements for Oral, Inhalation and Parenteral Routes
- Divides Metals into classes 1, 2A, 2B and 3.
- Class 1 – most toxic, must be included in all risk assessments
- Class 2A – high probability of exposure in drug products, must be included in all risk assessments
- Class 2B – reduced probability of exposure in drug products, can be excluded from risk assessments unless intentionally added
- Class 3 – low toxicity by oral route of exposure, can be excluded from risk assessments unless intentionally added for oral products
