Elemental Impurities Determination for Pharmaceuticals

Elemental impurities (EI) are a potential hazard in drug products: it is necessary to monitor their presence and their limits must be contained under acceptable concentrations. Pharmacopeias set binding limits for metal residues in pharmaceutical products and developed methods for their control, too.

Elemental Impurity Brochure

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Complete List of Technologies

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Elemental Impurities Determination for Pharmaceuticals: Our Lab

Mérieux NutriSciences | Pharma & Healthcare stands out with its unparalleled expertise and cutting-edge capabilities in elemental impurities analyses. With a proven track record of collaboration with leading pharmaceutical companies and a dedicated R&D team, we deliver exceptional quality and reliability in our testing services. Partner with us for accurate, innovative, and comprehensive analytical solutions.

Expertise & Know-How

Over 35 years of expertise in elemental analyses: decades of experience ensuring precision and reliability.
High throughput routine determinations of elemental impurities: analyzing over 800 samples per day across various matrices.

Experience

Extensive collaboration with international pharmaceutical companies: more than 15 years of trusted partnerships.
Proven experience in EI analysis in several matrices: pharma, foods, cosmetics, wastes, packaging, etc.

The Team

Dedicated R&D Team: A specialized team committed to advancing research and development for our clients.

Our Services

Mérieux NutriSciences | Pharma & Healthcare employs state-of-the-art technologies and more than 35 years of expertise in elemental analyses and quantitative determination of elemental impurities in a wide range of matrices, such as:

excipients, additives and raw materials
active pharmaceutical ingredients (APIs)
finished pharmaceutical products
food supplements (including OTC products)
cosmetics (including OTC products)
medical devices
packaging and containers
food products
environmental samples (air, water, soil)

Elemental impurities in drug products may arise from several sources, as residual catalysts that were intentionally added in synthesis or present as impurities.

Determination of elemental impurities in active pharmaceutical ingredients, medicinal products, and raw materials, plays a crucial role in pharmaceutical development and manufacturing.

The implementation of a strategic approach in compliance with ICH Q3D and USP requirements is imperative to ensure the safety and quality of drug substances or finished drug products.

Elemental impurities need to be monitored in drugs because:

They may be toxic to humans;
They may interfere with drug stability and shelf-life;
They may cause unwanted side effects to humans.

In Mérieux NutriSciences | Pharma & Healthcare chemical labs, two testing options are available for Elemental Impurities determination:

Method Validation Strategies

Mérieux NutriSciences | Pharma & Healthcare establishes, conducts, and authenticates a distinct procedure for each specimen following the directives for elemental impurities. Furthermore, an analysis of three separate batches will be executed to fulfil the risk evaluation mandates stipulated by ICH Q3D. Such a strategy facilitates the provision of an analysis certification for standard issuance and batch testing.

Method Suitability & Verification Strategies

Mérieux NutriSciences | Pharma & Healthcare has developed a proprietary screening technique on the specimen to evaluate its appropriateness for identifying elemental impurities within the particular sample context. Following an initial examination, this technique will be employed to scrutinize the elemental impurities across three separate batches to finalize the risk evaluation as mandated by ICH Q3D. Fields of application:

Non-GMP – Suitability verification of official/in-house validated methods applied to preliminary screening test;
GMP – Suitability verification of methods validated on worst-case products and applied to similar products.

Regulatory References

Guidance From the International Conference of Harmonization

ICH Q3D guideline aims at limiting the presence of Elemental Impurities in drug products using the principles of risk management as described in ICH Q9: Risk-Based Quality Control Strategy.

New Challenges Introduced by the ICH Q3D Guideline

Identification of toxicologically relevant Permitted Daily Exposure (PDE) limits for individual elements – a substance-specific dose that is unlikely to cause adverse effects to the individuals who are daily exposed to this dose or lower, during their life;
RISK-BASED approach to assess the likelihood of elemental impurities being present in drug products;
Inductively Coupled Plasma (ICP): new analytical methodology setting new, specific limits for individual elements and replacing the wet chemical “heavy metals” limit test;