* NEW * Standards for Elemental Impurities in Pharmaceuticals ICH Q3D

Reagecon has introduced a NEW range of Standards for ICP, ICP-MS Elemental Impurities ICH Q3D, in the context of Pharmaceutical products, almost all of the major pharmacopoeias have published new regulations pertaining to Elemental Impurities. This publication presents in clear and concise detail, the history that predated these new regulations, the new methods that are recommended and specifics relating to why such regulations are now being enforced.

The hazard classification and Permitted Daily Exposure (PDE) limits depending on route of ingestion are detailed in a simple to follow table. A complete range of appropriate Standards are offered by Reagecon. These Standards, of which there are 17 in total, are presented in exactly the concentrations mandated in the Pharmacopoeias as being the PDE applicable to Oral, Parenteral or Inhalation ingestion.

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