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Elemental Impurity Analysis in Pharmaceuticals: Validating performance of an Agilent 7800 ICP MS

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Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. To achieve this, potentially toxic and harmful contaminants – including elemental impurities – must be identified, and limits defined for their maximum allowable intake. Limits for impurities are defined by national and regional bodies such as the United States Pharmacopeial Convention (USP), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the European, Chinese and Japanese Pharmacopoeias (Ph. Eur. ChP and JP)

Elemental impurity analysis plays an important role in any pharmaceutical development and manufacturing and it is now vital and mandatory for pharmaceutical organizations to demonstrate compliance to the specified levels of elemental impurities in chapter <232> and ICH Q3D [3].

Many labs that perform pharmaceutical analyses may be unfamiliar with ICP techniques. Agilent’s comprehensive workflow solution focuses on ease of use, from sample preparation to method setup, analysis and reporting. Agilent has been a leading provider of instrumentation, guidance and technical support for companies setting up to perform elemental impurity analysis. Agilent’s systems are widely used and trusted in the pharmaceutical industry, delivering reliable and high-quality data, backed up by market-leading support, qualification services and compliance solutions. Agilent 7800 ICP-MS can determine all regulated elements at the required levels in a range of pharmaceutical samples.

Features:

  • Reduce sample preparation –Unique High Matrix Introduction (HMI) technology, standard on the 7800 ICP-MS, lets you analyze samples containing up to 3% total dissolved solids (TDS) without dilution, reducing sample preparation and saving time.
  • Minimize signal suppression – HMI reduces signal suppression, so high matrix samples can be measured accurately without requiring matrix matched calibration standards.
  • Ensure accurate data with effective interference removal – Helium (He) collision mode simplifies method development and routine operation by removing polyatomic ion interferences under a single consistent set of conditions. He mode avoids the need for matrix or analyte-specific reaction cell conditions.
  • Analyze major and trace analytes in a single run –The wide dynamic range orthogonal detector system (ODS) enables direct analysis of major elements (100s or 1000s of ppm) and trace level analytes (single or sub-ppt) in a single run. The high upper concentration limit reduces sample reruns caused by over-range results.
  • Maximize throughput and productivity –The optional Integrated Sample Introduction System  (ISIS 3) and the SPS 4 Autosampler lower your cost per analysis without compromising data quality

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