USP 232 and 233 Pharmaceutical Elemental Impurity Testing

Your USP Chapter 232/233 Testing Partner
We offer expert GMP elemental impurity analysis services according to USP General Chapter <232> and USP Chapter <233> which are Good Manufacturing Practice (GMP) compliant and are conducted in accordance with these USP chapters to support your raw materials quality control testing, reference materials certification, stability testing and GMP batch release testing. Additionally, our experts have in depth knowledge in the implementation of ICH 3QD Guideline for Elemental Impurities and can provide combined toxicological risk assessment and testing compliance services in order to meet all your regulatory requirements.

At Intertek, we have established a strategic approach, which includes options for semi-quantitative screening, method development and validation (as either a limit test or a quantitative test as dictated by the client’s analytical needs) and routine analysis. Our expertise in sample preparation ensures that we meet the challenges of difficult samples which have poor solubility enabling very low levels of detection (i.e. at toxicologically relevant levels, such as parts per billion or lower in solution). Our GMP facilities are equipped with both inductively coupled plasma – mass spectrometry (ICP-MS) or inductively coupled plasma – optical emission spectroscopy (ICP-OES) technologies.