The FDA is requiring compliance of drug manufactures to meet the new standards for elemental
impurities. These impurities include those that are naturally occurring or introduced to the product
during the manufacturing process.
Our team of PhD chemists is well versed in USP 232/233/2232 testing. Here is some of our research:
- Case Study: Identify USP 232 Impurities in Drug Delivery Systems
- Elemental impurities testing services
- Regulatory testing services
Prior to the introduction of USP 232 and 233 guidance on elemental impurities was found in ICH QD3.
This document established the permitted daily exposure (PDE) for 24 toxic metals.