Genotoxic Pharmaceutical Impurities Analysis

Genotoxic Pharmaceutical Impurities Analysis
Product Description

Our GCP/GLP/GMP compliant laboratories provide genotoxic impurity testing services to detect and evaluate the potential of GIs for your API and/or drug substances which can support your product development from an early stage to market release. With scientists who are adept at method development and validation of suitable analytical procedures, we can overcome the challenges of low detection levels and difficult matrices. Using a range of technologies we can apply an orthogonal approach to ensure robust, specific and sensitive analysis. Our comprehensive characterisation techniques include:

  • High Performance Liquid Chromatography with (HPLC with UV/Vis detectors)
  • Gas Chromatography (GC) and GC-MS
  • Liquid Chromatography-Mass Spectrometry (LC-MS)
  • Inductively-Coupled Plasma Optical Emission Spectroscopy
  • (ICP-OES) and Inductively- Coupled Plasma Mass Spectrometry (ICP-MS)
  • Nuclear Magnetic Resonance Spectroscopy (NMR)
As part of our comprehensive stability study capability, we examine degradation products under stressed conditions to help establish degradation pathways. Additionally, we offer highly sensitive and specific method development and validation expertise which is required to address the issues of genotoxic impurities including nitrosamines screening and quantification.

Toxicological Risk Assessment
With many years of experience in toxicological risk assessments, our consultants conduct risk assessments to address the issues associated with exposure to genotoxic impurities and other substances of concern including residual solvents, process impurities, extractables & leachables, elemental impurities (ICH Q3D) and other substances that may find their way into a pharmaceutical product.

read More: https://www.intertek.com/pharmaceutical/gmp-cmc-laboratory/genotoxic-impurities-analysis/

Read more Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile
Categories
more categories Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile

More Products from Intertek Analytical Services (99)

  • cGMP Pharmaceutical Quality Control Testing

    Product cGMP Pharmaceutical Quality Control Testing

    QC testing of pharmaceutical raw materials to international pharmacopoeia specifications has become a specialty of Intertek. With our knowledge of analytical chemistry and our vast range of instrumental techniques, we can undertake the vast majority of the chemical tests listed within the international pha...
  • Cleaning Validation Analysis Support for Pharma Production

    Product Cleaning Validation Analysis Support for Pharma Production

    Our analytical scientists provide cleaning validation analysis from our GMP compliant laboratories. We ensure that fit-for-purpose analytical methods are specific for the substances being assayed and suitable to detect contaminants at the specified ARL for an appropriate level of cleanliness (sensitivity)....
  • Elemental Impurities Testing

    Product Elemental Impurities Testing

    Our elemental impurities experts and toxicologists can help you to develop a compliance strategy to achieve successful implementation of ICH Q3D requirements. Intertek's GMP laboratory services teams facilitate the process through the design of tailored analytical programs based on wide experience of pharm...
  • Extractables and Leachables Studies

    Product Extractables and Leachables Studies


    Regulatory agency expectations are continually evolving with ever more stringent requirements for the evaluation of drug product packaging associated with each new product. Our extractables and leachables scientists based at our GMPscientists conduct E&L analysis studies in accordance with regional g...
  • Formulation Development Contract Services

    Product Formulation Development Contract Services

    Our drug product formulation development teams offer design and optimisation of formulations for powders, capsules, liquids and solids, semi-solids, inhaled, nasal, nebulised, pressurised and topical drug formulations. We provide focused understanding from an early stage of development tailored to your new...
  • GCP/GLP Bioanalysis Services

    Product GCP/GLP Bioanalysis Services

    In our state-of-the-art facilities, we provide GLP/GCP method development, validation, method transfer, sample analysis and pharmacokinetic and toxicokinetic support, along with automated data collection and reporting systems. Over the past 20 years, we have supported the development of pharmaceuticals, bi...
  • GMP and CMC Pharmaceutical Laboratory Services

    Product GMP and CMC Pharmaceutical Laboratory Services

    We provide regulatory-driven, phase-appropriate, CMC laboratory and GMP pharmaceutical laboratory services. Our expertise ensures sufficient information for your Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings. This is achieved through analysis...
  • ICH Pharmaceutical Stability Testing and Storage

    Product ICH Pharmaceutical Stability Testing and Storage

    With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlled and monitored...
  • ICH Stability Testing, Storage & Program Management

    Product ICH Stability Testing, Storage & Program Management

    Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every location. We have 24-hour alarm systems at all sites with dedicated teams on...
  • Inhalation Drug Product Development Services

    Product Inhalation Drug Product Development Services

    With 30 years of experience in supporting development of inhalation drug products for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, device verification testing,...
  • Inhaled Biologic Drug Development

    Product Inhaled Biologic Drug Development

    Intertek has over 30 years’ experience in biologics characterisation, from small peptides up to monoclonal antibodies and conjugated species, and contract testing, formulation and clinical manufacturing services supporting orally inhaled and nasal drug product development. The Intertek Centre of Excellence...
  • Medical Device Testing

    Product Medical Device Testing

    Our medical device testing experts provide scientific solutions for wound care, stents, cardiovascular implants, dermal fillers, orthopaedic implants, bone cement, biomaterials, catheters, in vitro diagnostics, combination products such as pre-filled syringes or inhaled drug products, and dental or surgica...
show all 99 other products

Intertek Analytical Services resources (2)

  • Boosting in Vitro Testing for Nasal Drug Products

    News Boosting in Vitro Testing for Nasal Drug Products

    In Vitro Test Methods for Nasal Drug Products VIDEO: Learn how our Alberta Idealised Nasal Inlet (AINI) capability can deliver enhanced IVBE studies for generics and support the development of novel intranasal products targeting specific nasal regions 
    14 Sep 2022
  • Brochure - Pharmaceutical Services

    Brochure Brochure - Pharmaceutical Services

    Covering our full breadth of contract laboratory services, auditing and regulatory consultancy expertise, this brochures provides a summary of our global capabilities.
    Visit www.intertek.com/pharmaceutical for more information.