As a player in the pharmaceutical industry, you are subject to strict requirements regarding the quantification of elemental impurities, which may be toxic, in your raw materials, active pharmaceutical ingredients (APIs), or finished pharmaceutical forms. FILAB laboratory performs impurity analysis adapted to active substances, excipients, and finished products, incorporating the requirements of USP 233 and associated regulatory expectationss.
Your needs: perform a USP 233 analysis of your pharmaceutical products to identify elemental impurities
What is USP 233?
USP 233 is a general chapter of the United States Pharmacopeia, specifically dedicated to the analysis of elemental impurities.
USP 233 establishes requirements for analytical method validation, particularly for the quantification of elemental impurities. It imposes strict criteria for the accuracy, specificity, and sensitivity of analysis, prioritizing the use of ICP-MS and ICP-OES.
Objectives of elemental impurity analysis
The USP 233 Elemental Impurities – Procedures standard complements USP 232, which defines the acceptable toxicological limits for elemental impurities, particularly trace metals.
USP 233 impurity analysis makes it possible to:
- verify the regulatory compliance of products
- secure registration and variation dossiers
- demonstrate the reliability and robustness of the analytical methods used
Elemental impurities according to USP 233
Scope of elemental impurity analysis according to USP 233
Raw materials or excipients (of natural or synthetic origin)
Active substances (APIs)
Catalysts used in chemical synthesis
Contact materials (containers, manufacturing equipment)
Industrial processes themselves
Products derived from biotechnology or combination products
Finished products (oral, injectable, topical, inhaled dosage forms)
USP 233 does not directly establish specific limits for each element, but provides the analytical framework. The thresholds to be observed are defined in USP <232> and harmonized with the ICH Q3D guideline.
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Our solution: work with FILAB, a USP 233 analytical laboratory, to ensure product compliance with regulatory requirements for impurities
Our USP 233 analysis services
Our laboratory supports pharmaceutical companies in bringing their products into compliance with the USP 233 standard, at every stage of the product life cycle: development, analytical transfer, quality control, or regulatory dossier preparation. Thanks to our expertise and state-of-the-art analytical facilities, we provide reliable, accurate, and fully documented analysis.
Quantification of elemental impurities
Assessment of compliance with repeatability, accuracy and precision criteria, as defined in <USP 233>
Robustness and linearity testing as part of analytical development or transfer
analysis by ICP-MS (Inductively Coupled Plasma – Mass Spectrometry) and ICP-OES (Optical Emission Spectrometry)
Method validation studies for routine use in a GxP/GMP environment
Our technical capabilities
USP 233 application areas
Initially designed for the US pharmaceutical market (FDA), the USP <233> standard is now widely adopted internationally. Aligned with the requirements of ICH Q3D, it applies to products intended for Europe, Canada, Japan and many other countries. It is an essential reference for manufacturers and CDMOs operating in global markets.
Your industrial challenges
verify the regulatory compliance of active substances, excipients or finished products
identify and quantify elemental impurities that may affect safety
investigate non-compliance or exceedances of trace-metal thresholds
secure a change in raw material, supplier or manufacturing process
support development, quality control or regulatory submission phases
Application cases
Challenge: Metallic impurities are detected at non-compliant levels in an active substance.
Analytical solution: Implementation of an elemental impurity analysis in accordance with USP <233> by ICP-MS, with method validation on the API matrix and interpretation of the results against the USP <232> thresholds.
Challenge: Unknown impurities appear during a stability study of a pharmaceutical product.
Analytical solution: Analysis of organic impurities by LC-MS and GC-MS to identify the compounds, assess their origin and secure the product’s impurity profile.
Organic impurity analysis
In addition to the requirements of USP <233>, the laboratory offers organic impurity analysis. These analysis help document the impurity profile, identify unknown compounds, and ensure quality monitoring throughout the product life cycle.
Additional analysis
Our FAQ
Impurity analysis involves identifying and quantifying unwanted compounds present in a substance or product to ensure its quality and safety.
- International regulatory compliance : essential for FDA and EMA registrations or for meeting the requirements of international customers.
- Patient safety: ensuring the absence of heavy metals at toxic levels.
- Result reliability: validated and sensitive methods compatible with complex matrices.
- Alignment with ICH Q3D: USP <233> provides a framework compatible with other applicable regulations.
Whether you are in the development, analytical transfer, or batch release phase, performing analysis according to USP <233> is essential to meet the applicable standards. These techniques make it possible to detect very low concentrations of elements, at ppb or ppm levels, with high accuracy and reproducibility.
Organic impurities are carbon-containing compounds originating from the process or degradation, whereas elemental impurities mainly consist of trace metals.
Analysis according to USP <233 is required during development, process validation, quality control, or as part of a regulatory submission to the United States Pharmacopeia.
Active substances, excipients, and finished pharmaceutical products are subject to impurity analysis.
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