Latest research

  1. Article

    Simple sensitive ICP-MS method development and validation for quantitative evaluation and risk assessment of elemental impurities in anticoagulant drug product: study aligned with ICH Q3D guideline

    • Shriram Pandurang Suryawanshi
    • Gayatri Barabde

    Background Elemental impurities in pharmaceutical products present significant risks to patient safety due to their potential toxicity. These impurities may arise from various sources, including raw materials used in the process, manufacturing...

    23 September 2026 Open access
  2. Article

    ISO 7218:2024 in official control food microbiology laboratories: key revisions, quality implications, operational challenges, implementation considerations, and opportunities for harmonization

    • Panagiota Gousia
    • Katerina Gotzamani

    The updated version of ISO 7218:2024, titled “Microbiology of the food chain—General requirements and guidance for microbiological examinations”, serves as a significant horizontal standard that underpins microbiological testing throughout the food...

    17 September 2026 Open access
  3. Article

    Eco-Friendly Quality by Design-Based LC–MS/MS Method for the Determination of Nitrosamine Impurities in Triamcinolone Acetonide Pharmaceutical Products

    • Lalitha Repudi
    • Mohana Vamsi Nuli
    • Kumaraswamy Gandla

    Purpose Nitrosamine impurities are highly potent genotoxic contaminants that present significant safety concerns in pharmaceutical products, necessitating sensitive, robust, and environmentally sustainable analytical methods for their trace-level...

    16 September 2026
  4. Article

    A Novel Assay Platform for Targeted Protein Degradation Monitoring: Case Study of Antibody Free Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) for MALT1 Target Quantification

    • Feng Jin
    • Craig Wallace
    • Qin C. Ji

    The mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) is a central regulator of inflammatory signaling downstream of immunoreceptor tyrosine-based activation motif-containing receptors and G protein-coupled receptors...

    15 September 2026
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