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, Parental or Inhalation ingestion.
Substantial detail is presented on the features and benefits of this unique product offering. A wide range of certified High-Quality Matrix Solutions are also offered.
Standards for Elemental Impurities in Pharmaceuticals as applied to:
- ICH Q3D
- USP <232>, <233>, <2232>
- EP General Test 520 (General Method 2.4.20)
- Chinese Pharmacopoeia
- Japanese Pharmacopoeia
- Other Pharmacopoeia
Table of Contents
- History of Elemental Impurities in Pharmaceuticals
- New Methods for Impurity Measurement
- Context of the New Methods
- Hazard Classification (depending on route of ingestion)
- Permitted Daily Exposure Limits
- Oral Ingestion Standards
- Parenteral Ingestion Standards
- Inhalation Ingestion Standards
- Non‐Classified Element Standards
- Matrix Materials
- Certified High Purity Solutions for Trace Analysis