Product/Service

Chemical Analysis

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Partnering with Nelson Labs Europe, Stevanato Group’s laboratories can supply the most advanced and comprehensive chemical characterization of the primary packaging to detect and mitigate the risk of chemical interaction with drugs. We can assist in E&L analysis providing a multi-analytical approach for the selection of the proper container closure systems at each stage of the drug development journey.

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Capabilities and testing

  • Full Delamination Propensity Studies (According to USP <1660> Guideline)
  • Extractables Studies on Polymer/ Rubber Container/Closure Components
  • Pre-Screening and “Formal” Leachables Studies
  • Identification of “Unknown Extractables” and Impurities in Drug Products
  • Silicone quantification
  • Tungsten Analysis
  • Contamination Identification and Material Characterization
  • Pharmacopoeias (USP, EP, JP) Testing

Analytical techniques:

  • Headspace GC/MS: Volatile Organic Compounds
  • GC/MS or GC/QQQ: Semi-Volatile Organic Compounds
  • GC-Q-Tof: Semi-Volatile Organic Compounds
  • LC/QQQ: Non-Volatile Organic Compounds
  • LC/High-Resolution MS: Non-Volatile Organic Compounds
  • UPLC-Q-Exactive Orbitrap: Non-Volatile Organic Compounds
  • ICP/OES and ICP/MS: Metals & Elements (at trace level)
  • Ion Chromatography: Anions
  • FT-IR Spectrometer: Organic Compounds/Materials and silicone quantification
  • FT-IR Microscope: Organic Compounds/Materials at Trace Level
  • UV-Vis Spectophotometer: Transmittance Measurement

Stevanato Group