Elemental Analysis and Trace Metals Testing for Pharmaceuticals
Trace metals analysis and organic elemental analysis services to support clients involved in drug development and manufacturing of pharmaceuticals, biopharmaceuticals, specialty chemicals, biocides, contamination testing and more.
Trace metals testing is a routine activity in our network of Good Manufacturing Practice (cGMP) analytical laboratories. The elemental analysis teams provide either Pharmacopeia methods or develop clients specific methods. Intertek has provided Inductively Coupled Plasma (ICP) with both Mass Spectrometry (MS) and Optical Emission Spectroscopy (OES) detection metals analysis services since 1990 including heavy metals testing. Intertek has established approaches in house to address the forthcoming changes to the United States Pharmacopeia (USP) new General Chapters relating to the determination of elemental impurities in pharmaceutical products and ingredients. USP<232> defines the analyte limits, while USP<233> defines sample preparation options including closed vessel microwave digestion utilising multi-element ICP-MS and ICP-OES techniques.
Intertek has significant experience in the analysis of drug related organic and inorganic elements, providing coverage of the entire periodic table from trace levels to percentage levels. The test methods are qualified for accuracy and precision. For 21CFR Part 210 and 211 protocols for release of finished products, registration stability and clinical trials support, Intertek offers compound specific methods that are validated in accordance with a validation protocol and acceptance criteria to support the intended use. Quality Control testing and GMP batch release testing are routine services carried out in our network of GMP compliant laboratories.
Inorganic Elemental Analysis:
- Compositional Elemental Analysis of raw materials, pharmaceutical drug substance or drug products
- Pharmacopeia heavy metals testing
- Pharmacopeia USP metals testing
- Highly automated determination of 63+ elements
- Expertise with preparation of difficult sample types in various matrices
- Anions and cations determination by Ion Chromatography (IC)
- Rapid semi-quantitative elemental analysis of unknowns
- Determination of trace contaminants in raw materials and products
- High throughput evaluation of active deposition on skin, hair, fabrics
- Bioanalysis for clinical samples (plasma, tissue, whole blood) GLP or GCP
- ICP-MS (75 elements)
- ICP-OES (63+ elements)
- Flame Atomic Absorption Spectroscopy (FLAA), Graphite furnace atomic absorption spectrometry (GFAA), Cold Vapor Atomic Absorption (CV-AA)
- X-Ray Fluorescence (XRF)
- Ion Chromatography (IC)
Organic Elemental Analysis:
- Pharmaceutical compositional Analysis
- Impurity identification and quantitation
- Compound characterization
- Reference Standard certification
- LC-MS/MS analysis
- CHNO, CHNS combustion analysis
- Gas chromatography (GC), Gas chromatography - Mass Spectrometry (GC-MS), GC-FID
- Spectroscopy (Infra-Red (FT-IR, Diamond ATR/FT-IR) UV/Vis, Optical Rotation, Nuclear Magnetic Resonance (NMR - H1 and C13)
- Titrations (colormetric, ion specific, Karl Fisher, potentiometric)
- Total organic carbon
Pharmaceutical analysis and other services:
Request more information to see how Intertek can help your organization with Elemental Analysis and Trace Metals Testing for Pharmaceuticals.