Elemental Impurity Studies
Elemental impurities — residual metals that can enter a drug substance or drug product from raw materials, catalysts, water, equipment or packaging — are controlled globally under ICH Q3D. DALPL's Pharma Testing Division tests and validates methods for all 24 ICH Q3D-classified elements against the current requirements of ICH Q3D, the newly harmonized USP General Chapters <232> (Elemental Impurities—Limits) and <233> (Elemental Impurities—Procedures), the EMA guideline, and customer-specific requirements.
Testing Scope
Active Pharmaceutical Ingredients (APIs) / Drug Substance
Drug Products
Tablets, Capsules, Injectables, Ointments, Lotions, Syrups, Suspensions, Gels, Inhalations, Creams & Emulsions, Transdermal Patches
Raw materials, intermediates and excipients
Our Elemental Impurity Testing Services
Testing and Quantification
Testing and quantification of all 24 ICH Q3D-classified elemental impurities (Class 1, 2A, 2B and 3), risk-assessed by route of administration.
Regulatory / Compendial Testing
Elemental impurity analysis according to ICH Q3D, USP <232>/<233> (harmonized with Ph. Eur., JP and IP, official May 2026), the EMA guideline, and/or customer-specific requirements.
Method Development & Validation
Method development and validation, including quantitative procedures validated for accuracy, precision, specificity, linearity, range and limit of quantitation.
Matrix-Specific Sample Preparation
Sample preparation by both conventional and microwave digestion, matched to sample matrix.
Batch Analysis & Regulatory Reporting
Batch analysis and regulatory reporting.
Customised Analytical Solutions
Customised analytical solutions for specific elements, matrices or client validation protocols.
Analytical Capabilities
Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Sample Preparation
Why DALPL
Delivering high-accuracy impurity profiling with uncompromised regulatory integrity.
