Chemistry
Chemical Analysis: Detailed Chemical Evaluation Protocol / Report
A custom chemical characterisation protocol and report written to the expectations of the US FDA for ISO 10993-18:2020 data — AET calculation, extraction rationale, and a full listing of equipment, settings and acceptance criteria — so the chemistry you submit is reviewable as well as correct.
Chemical Analysis: Heavy Metals, Total Content (34 Elements)
Total content heavy metals analysis by microwave digestion with ICP-MS and ICP-OES, following ISO 10993-18.
Chemical Analysis: Non-Volatile Organic Compounds (NVOC), Screening of migrate in Isopropyl Alcohol
Non-volatile organic compound screen of a isopropyl alcohol (IPA) migrate by HPLC/Q-ToF/MS, following ISO 10993-18.
Chemical Analysis: Non-Volatile Organic Compounds (NVOC), Screening of migrate in Water
Non-volatile organic compound screen of a water migrate by HPLC/Q-ToF/MS, following ISO 10993-18.
Chemical Analysis: Non-Volatile Organic Compounds (NVOC): Screening of migrate in n-Hexane
Non-volatile organic compound screen of a n-hexane migrate by HPLC/Q-ToF/MS, following ISO 10993-18.
Chemical Analysis: Non-Volatile Residue (NVR) in Isopropyl Alcohol (IPA) - Gravimetric
Gravimetric determination of non-volatile residue (NVR) in a isopropyl alcohol (IPA) extract.
Chemical Analysis: Non-Volatile Residue (NVR) in n-Hexane - Gravimetric
Gravimetric determination of non-volatile residue (NVR) in a n-hexane extract.
Chemical Analysis: Non-Volatile Residue (NVR) in Water - Gravimetric
Gravimetric determination of non-volatile residue (NVR) in a water extract.
Chemical Analysis: Semi-Volatile Organic Compounds (SVOC), Screening of migrate in Isopropyl Alcohol (IPA)
Semi-volatile organic compound screen of a isopropyl alcohol (IPA) migrate by GC/MS, following ISO 10993-18.
Chemical Analysis: Semi-Volatile Organic Compounds (SVOC), Screening of migrate in n-Hexane
Semi-volatile organic compound screen of a n-hexane migrate by GC/MS, following ISO 10993-18.
Chemical Analysis: Semi-Volatile Organic Compounds (SVOC), Screening of migrate in Water
Semi-volatile organic compound screen of a water migrate by GC/MS, following ISO 10993-18.
Chemical Analysis: Total Organic Carbon (TOC), O.I. Device Extraction (GLP)
Quantitative determination of total organic carbon (TOC) in an aqueous device extract.
Chemical Analysis: Volatile Organic Compounds (VOC), Screening of migrate in Water
Volatile organic compound screen of a water migrate by headspace GC/MS, following ISO 10993-18.
- Turnaround band
- Standards
- Endpoint
- Subcontracted