Elemental Impurities Analysis

Elemental impurities in drug products may arise from several sources; they may be from residual catalysts that were added intentionally in synthesis or may be present as impurities. Because elemental impurities do not provide any therapeutic benefit to the patient and also are harmful, their levels in the drug product have to be controlled within acceptable limits. ICH Q3D classifies the elemental impurities in classes based on their toxicity and the intended route of drug usage:

Class 1: The elements, As, Cd, Hg, and Pb, are human toxicants and generally come from commonly used materials such as excipients.

Class 2: Elements in this class are generally considered as route-dependent human toxicants. Class 2 elements are further divided into sub-classes 2A and 2B based on their relative likelihood of occurrence in the drug product

Class 3: The elements in this class have relatively low toxicities by the oral route of administration (high PDEs, generally > 500 µg/day) but may require consideration in the risk assessment for inhalation and parenteral routes.

Other elements: Some elemental impurities for which PDEs have not been established due to their low inherent toxicity and/or differences in regional regulations are not addressed in the ICH Q3D guideline. If these elemental impurities are present or included in the drug product like Al, B, Ca, Fe, K, Mg, Mn, Na, W, and Zn then they may also be required to be monitored as per the regulatory requirements.

Shiva Analyticals offers a complete range of elemental impurities testing on:

• ICP MS – Agilent 7700X
• ICP MS – Agilent 7800X
• ICP OES – Perkin Elmer 5300DV
• ICP OES – Perkin Elmer Avio 200
• AAS – Agilent 200 Series GTA 120 Graphite Furnace
• AAS – Agilent 289 FS with GTA

Shiva Analyticalls has over three decades of experience in the analysis of elemental impurities in raw materials, drug substances, excipients, and drug products, and having handled hundreds of different products gives an edge to quicker turnarounds in analytical method development, method validations, and release testing with reproducible results.

Please contact us to get a quotation for the analysis of elemental impurities as per the ICH Q3D.