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Chemical Analysis - Stevanato Group
Stevanato Group’s laboratories can supply the most advanced and comprehensive chemical characterization of the primary packaging. Chemical Analysis.
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Chemical Analysis

Analyzing glass primary packaging and components
to mitigate the risk of chemical interaction with drugs

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.

Capabilities and testing

31A_delamination
Full Delamination Propensity Studies (According to USP <1660> Guideline)
41 Syringe Plunger
Extractables Studies on Polymer/ Rubber Container/Closure Components
67 Chemical Analysis
Pre-Screening and “Formal” Leachables Studies
89B Filled Cartridge Particles
Identification of “Unknown Extractables” and Impurities in Drug Products
15A Cartridge Siliconized Int
Silicone quantification
271 Syringe Lowtungsten
Tungsten Analysis
66 Surface Characterization
Contamination Identification and Material Characterization
25 Regulatory Expertise
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
Stevanto Group Webinar Delamination - 052820
▶
WATCH THE WEBINAR
WEBINAR
ON DEMAND
Glass Delamination: Holistic approach for characterization and control
50 min MIN.
ENGLISH
ON DEMAND
WEBINAR
Glass Delamination: Holistic approach for characterization and control
50 min MIN.
ENGLISH
Interested in Chemical Analysis?
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