United States Pharmacopeia (USP) <232> and <233> elemental impurities testing in drug products including screening and quantification of potentially toxic metal impurities

United States Pharmacopeia (USP) chapters <232> Elemental Impurities-Limits and <233> Elemental Impurities-Procedures specify limits and procedures for elemental impurities in drug products. 

To reduce risks associated with potentially toxic and harmful elemental impurities, these must be identified and limits defined for maximum levels that a patient should be exposed to. Elemental impurity analysis plays an important role in pharmaceutical development and manufacturing, particularly due to the known toxicity and the potential for contamination by lead (Pb), mercury (Hg), arsenic (As) and cadmium (Cd). It is vital to demonstrate compliance to the USP <232> elemental impurities specified levels where impurities such as Pb, Hg, As and Cd are known to be present or could potentially be introduced during manufacture via raw materials, reagents or processing equipment. These levels can, in certain cases, be extremely low.

New USP Chapter 232/233 Became a Requirement on January 1, 2018
The USP Chapter 232/233 became a requirement for pharmaceutical companies on January 1, 2018. Now all companies should comply with both the USP <232> and USP <233> standards for elemental impurity limits and procedures which will serve as the overarching standards for elemental impurity testing for pharmaceutical products for the US market.

 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.

With nearly 30 years of elemental impurity analysis experience. Our GMP laboratory centers of excellence are located in North America and Europe where our scientists apply the right approaches for your samples through cost-effective and efficient services. With the latest technology for sample preparation and approaches for pharmaceutical impurity analysis, we can effectively overcome any challenge presented by sample type and sample matrices. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.

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Requirements for Elemental Impurities Testing

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Requirements for Elemental Impurities Testing

Requirements for USP <232> and USP <233> elemental impurities testing in the United States. Download the paper
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