Elemental analysis and trace metals testing to support pharmaceutical development and GMP manufacturing by elemental composition and impurity quantification
Elemental analysis and trace metals testing are important for the commercial release of pharmaceutical products, stability studies and clinical trial support. Elemental composition and quantification of trace species assist in the confirmation of product identity, purity and quality.
Understanding the elemental composition of your raw materials, active pharmaceutical ingredients (APIs), excipients or formulations is critical to ensuring quality control. Where the elemental composition is unknown, a strategic approach, which rationalises effort and spend, is required.
Trace metals are known to be toxic and can affect the stability of a formulation and catalyst degradation. Accordingly, control during the manufacturing process is important. The presence of trace species at very low levels and samples with poor solubility can all present analytical challenges to elemental analysis.
Our analysts have significant experience in pharmaceutical organic and inorganic elemental analysis with coverage of almost the entire periodic table from trace levels to percent levels. Trace metals testing is a routine activity for our Good Manufacturing Practice (GMP) laboratories and is carried out in accordance with pharmacopeia methods such as the United States Pharmacopeia (USP) Chapters USP 232 and USP 233 for elemental impurities, client specific methods services, and for pharmaceutical impurity testing. We also provide combined toxicological risk-assessment and testing compliance services to meet the requirements of ICH Q3D Guidelines for Elemental Impurities.
Our experienced analysts apply a strategic approach to sample preparation for difficult samples and a range of analytical technology, relevant to your needs, including inductively coupled plasma – mass spectrometry (ICP-MS) or inductively coupled plasma – optical emission spectroscopy (ICP-OES), ion chromatography (IC), flame atomic absorption spectroscopy (FLAA) and X-ray fluorescence (XRF).
In accordance with the latest regulatory developments our experts design the most suitable, phase - appropriate, analytical package for your product. For 21CFR Part 210 and 211 to support the release of finished products, stability, reference standard certification and clinical trials support, we offer method development and validation where required, pharmaceutical analysis via validated analytical methods and acceptance criteria to support the intended use.
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