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Laboratory services

- Extractable, leachable, Glass delamination, Plastic Analysis, Elemental Analysis as per USP 232,233, 381, 661, 661.2, 1660, 1661, 1663, 1664, PQRI, BPOG
- Medical device analysis as per ISO 10993-17 & 18
- Analysis as per EMEA guideline
- Toxicological assessment
- All types of method development, validation, stability and batch analysis testing

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Analytical techniques

- Liquid Chromatography with Mass Spectrometer (LCMSMS)
- Gas Chromatography with Mass Spectrometer (GCMS/MS)
Single Quadrupole and Triple Quadrupole
- Inductively Coupled Plasma with Mass Spectrometer (ICPMS)
- Scanning Electron Microscope with EDS (SEM-EDS)
- High Performance Liquid Chromatography (HPLC)
- FTIR
- UV Spectrophotometer, etc.

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Laboratory accreditation

- Registered with USFDA
FEI No. – 3018238790
DUNS No. – 854208771
- ISO 9001: 2015 Certified
- National FDA Site Approved
- NABL Certification in Process
- MSME - Government of India Registered

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All the services you expect from a clinical trial lab
  • Extractables and Leachable
  • Nitrosamines
  • Glass Delamination
  • Method Development and Validation
  • Genotoxic Impurities
  • Elemental Impurity Analysis
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Explore our Main Services.

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Pathology Testing

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Chemical Research

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Advanced Microscopy

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    WELCOME TO LABORATORY

    Most qualified staff with expertise in pharma analytical techniques.

    Itrace is the solution provider in the field of analytical chemistry with current global regulatory perspective.

    Itrace shall ensure customer satisfaction by on-time delivery of reports with maintaining impartiality and integrity in its operations.

    Itrace is having one of the most experience team in the field of Extractable-Leachable, Nitrosamines, Genotoxic impurities, Glass delamination studies, Routine analysis, all types of Method development and Method validation analysis.

    Itrace will work in collaboration with our clients and will support them in successful submission of products in regulated markets.

    Welcome to Itrace Pharmaceutical Solutions, we are ready to assist you.

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    Unit No F-7, D-wing, Udyog Bhavan-2,
    Plot No. K-2, Additional Ambernath
    Industrial Area,
    Ambernath (East), Thane – 421506

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    Sunday – Closed

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