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USP <232> Elemental Impurities—Limits

USP <232> is a standard that sets limits for elemental impurities in drug products. These impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. The standard specifies permissible levels for various elements, including arsenic, cadmium, lead, and mercury, which must be considered in the risk assessment due to their ubiquitous nature. The limits apply to drug products containing purified proteins and polypeptides, their derivatives, and products that contain these substances. However, the standard does not apply to products based on genes, cells, and tissue engineering. As the toxicity varies depending on the route of exposure, the limits are divided into oral, parenteral and inhalational exposure.

The relevance of the parameters measured in USP <232> lies in their ability to ensure the safety and efficacy of pharmaceutical products. Elemental impurities can pose significant health risks if present in excessive amounts. For instance, arsenic, cadmium, lead, and mercury are known to be toxic and can cause serious health issues. By setting strict limits on these impurities, USP <232> helps protect patients from potential harm.

The USP <232> links to USP <233> in case analytical testing is required. It recommends the use of Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES) or Inductively Coupled Plasma Mass Spectrometry (ICP-MS). These techniques offer high sensitivity and precision, allowing for the accurate quantification of elemental impurities. They also enable the analysis of complex matrices, making them suitable for a wide range of pharmaceutical products.

USP <232> is a critical standard for the pharmaceutical industry, providing guidelines for the permissible levels of elemental impurities in drug products.

With the PlasmaQuant MS series and the Plasma Quant 9100 series, Analytik Jena offers powerful, reliable and compliant solutions for ICP-MS and ICP-OES analyses to fulfill the requirements of the USP <232>. For further information please check the article on USP <233>.

 

Our solutions for USP <232>

PlasmaQuant MS Series Robust system for efficient, stable characterization of high matrix samples: PlasmaQuant MS offers excellent plasma robustness for high matrices, minimized drift at changing matrix load and efficient interference management with outstanding ease of use.

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PlasmaQuant 9100 Series The ICP-OES benchmark for the analysis of complex materials

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