Your needs: perform USP 233 analysis on your pharmaceutical products to identify elemental impurities
As a player in the pharmaceutical industry, you are subject to strict requirements when it comes to quantifying potentially toxic elemental impurities in your raw materials, active ingredients (APIs) or finished pharmaceutical forms.
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 sets out the requirements for the validation of analytical methods, in particular for the quantification of elemental impurities. It imposes strict criteria on the precision, specificity and sensitivity of analyses, with preference given to the use of ICP-MS and ICP-OES.
USP 233 applies to all products intended for pharmaceutical use, in particular :
Finished products (oral, injectable, topical and inhaled forms)
Biotechnology-derived products or combined devices
Elemental impurities according to USP 233
Elementary analysis
Raw material or excipients (natural or synthetic origin)
Catalysts used in chemical synthesis
Contact materials (containers, manufacturing equipment)
Industrial processes themselves
USP 233 does not directly set specific limits per element, but provides the analytical framework. The thresholds to be respected are defined in USP <232> and harmonised with the ICH Q3D directive.
Why carry out a USP 233 analysis for elemental impurities?
International regulatory compliance: essential for FDA and EMA registrations or to meet the requirements of international customers.
Reliability of results: validated and sensitive methods, compatible with complex matrices
Patient safety: guaranteeing the absence of heavy metals at toxic levels.
Harmonisation with ICH Q3D: USP <233> provides a framework that is compatible with the other regulations in force.
Whether you are in the development, analytical transfer or batch release phase, analysis in accordance with USP 233 is essential if you are to meet the standards. These techniques can detect very low concentrations of elements (in the ppb or ppm range), with a high degree of precision and reproducibility.
The search for elemental impurities according to USP 233: a speciality of the FILAB laboratory
Our USP 233 services
Our laboratory assists pharmaceutical manufacturers in bringing their products into compliance with USP 233, at every stage of the life cycle: development, analytical transfer, quality control or regulatory dossier. Thanks to our expertise and state-of-the-art analytical equipment, we can guarantee reliable, accurate and documented analysis.
Quantification of elemental impurities
Assessment of compliance with repeatability, accuracy and precision criteria, as defined in <USP 233>.
Robustness and linearity tests as part of analytical development or transfer
ICP-MS analysis (Inductively Coupled Plasma – Mass Spectrometry) et ICP-OES (Optical Emission Spectrometry)
Method validation studies for routine use in a GMP environment
Our technical resources
ICP-MS (Inductively Coupled Plasma Mass Spectrometry): for ultra-sensitive detection (ppb) of trace metals, even in complex matrices.
ICP-OES (Inductively Coupled Plasma Optical Emission Spectroscopy): for rapid analysis of a wide range of elements at higher concentrations.
Area of application of USP 233
Initially designed for the US pharmaceutical market (FDA), USP <233> is now widely adopted internationally. Aligned with ICH Q3D requirements, it applies to products destined for Europe, Canada, Japan and many other countries. It is an essential reference for manufacturers and CDMOs operating on world markets.
FAQ
USP <233> is an analytical method describing how to measure elemental impurities using techniques such as ICP-MS or ICP-OES. ICH Q3D, on the other hand, sets maximum permitted limits for each element. The two standards are complementary: USP <233> defines the ‘how’, ICH Q3D defines the ‘how much’.
A USP <233> laboratory has the equipment and expertise to analyse elemental impurities accurately and in accordance with regulatory requirements. These services are essential for FDA, EMA dossiers or internal quality audits.
Analysis in accordance with USP 233 and ICH Q3D applies to a wide range of pharmaceutical products: active pharmaceutical ingredients (APIs), excipients, finished medicines (tablets, injectables, topicals), as well as biotechnology products and combined devices..
The ICH Q3D directive defines exposure limits for elemental impurities (heavy metals and trace metals) in medicinal products. An ICH Q3D analysis can be used to assess and quantify these elements in active substances, excipients and finished products, in order to guarantee their safety for patients.