Nitrosamine Impurity Testing

Nitrosamine Impurity Testing
Product Description

Nitrosamine - testing for its impurities: Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) continue to be an area for concern as highlighted by the US FDA and other regulatory authorities. At Intertek we believe flexible solutions are the way forward to overcome technical challenges and achieve excellent LOD and LOQ values over a variety of techniques. This helps to mitigate issues such as instances of LC co-elution of NDMA and DMF, as well as other potential interferences, where present. This flexibility in platform approaches means we can apply sample and nitrosamine-specific, tailored analytical solutions that are highly relevant for your nitrosamine testing needs.

To learn more, visit our website:

www.intertek.com/pharmaceutical/news/nitrosodimethylamine-ndma-valsartan-drug-substance

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
Specifications
  • Supplied from
    United Kingdom; United States
More specifications Fewer specifications
Sales Markets
Show 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

More Products from Intertek Analytical Services (99)

  • Development and Validation of Analytical Methods

    Product Development and Validation of Analytical Methods

    Analytical methods development and validation: Our method development scientists work with a broad range of products, methods, and analytical technologies (chromatography, mass spectrometry, spectroscopy, biophysical analysis, bioanalytical techniques, etc.) to ensure that the method will meet its int...
  • Formulation Development including Inhaled Products

    Product Formulation Development including Inhaled Products

    Inhaled products and formulation development: The development of drugs using experimental design approaches with integrated stability testing and storage is available from us. Our formulation specialists can provide a wide range of formulations in a timely and cost-effective manner in order to identify t...
  • Nasal Drug Development

    Product Nasal Drug Development

    Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laborato...
  • Extractables and Leachables Testing Services

    Product Extractables and Leachables Testing Services

    Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...
  • Bispecific Antibody Characterisation

    Product Bispecific Antibody Characterisation

    Characterisation of bispecific antibodies supporting regulatory considerations for therapeutic development. Our scientists offer BsAb characterisation, with a focus on monitoring relevant CQAs. We can help you to demonstrate consistency or comparability of manufactured batches or as release tests for clin...
  • Inhalation Product Analysis and Testing

    Product Inhalation Product Analysis and Testing

    Inhalation product analysis and testing services include particle size and droplet characterization, delivered dose testing, as well as aerodynamic particle size analysis – for pressurized metered-dose inhalers (PMDI), dry powder inhalers (DPI), nebulizers, and soft mist inhalers. Our Good Manufacturin...
  • Antibody / Monoclonal antibody therapeutics services

    Product Antibody / Monoclonal antibody therapeutics services

    Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, ...
  • Gene Therapy Characterisation and Release Testing

    Product Gene Therapy Characterisation and Release Testing

    Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a...
  • Clinical Trial Supplies Manufacturing Services

    Product Clinical Trial Supplies Manufacturing Services

    Services for manufacturing clinical trial supplies: To meet your supply needs for investigational medicinal products (IMP) or investigational new drugs (IND) for clinical trials around the world, we provide GMP clinical trial materials manufacturing services. Integrated with raw material testing, ...
  • mRNA Characterisation and Analysis

    Product mRNA Characterisation and Analysis

    Characterization and analysis of mRNA supporting vaccine and therapeutic development, including assessing clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug product to help you confidently assess batch to batch manufa...
  • cGMP Cell-based Bioassays

    Product cGMP Cell-based Bioassays

    Cell-based bioassays that comply with cGMP: Using a variety of techniques, including cell-based assays, ligand and receptor binding assays, and flexible multiple assay approaches – our potency testing experts offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1)...
  • Analytical Research and Development Services

    Product Analytical Research and Development Services

    Services for analytical research and development: As your organization focuses on core business goals, you'll require a partner who has a history of providing consistently high-quality regulated compliance testing. Our team are focused on supporting product development, GMP manufacturing and distributio...
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.