Nitrosamine Impurity Testing

Nitrosamine Impurity Testing
Product Description

At Intertek we also offer a GC-MS/MS approach which has allowed our experts to achieve excellent LOD and LOQ values. Overall, GC has proved extremely useful for some difficult projects, helping us to present an alternative and successful route to avoiding challenges associated with Liquid Chromatography 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.

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Method for the Determination of NDMA in Ranitidine Drug Substance and Solid Dosage Drug Product

This method is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of NDMA in ranitidine drug substance and drug product. This LC-MS method based on a triple-quad platform may be used as an alternative or confirmatory method for the liquid chromatography high resolution mass spectrometry (LC-HRMS) method. The triple-quad platform is more widely available than the LC-HRMS platform.

Liquid Chromatography High Resolution Mass Spectrometry (LC-HRMS) Method for the Determination of NDMA in Ranitidine Drug Substance and Drug Product

The FDA have observed that the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities is not suitable for testing ranitidine because heating the sample generates NDMA. A LC-HRMS method was subsequently developed by the FDA to measure the levels of NDMA in ranitidine drug substance and drug product following ICH Q2(R1), with LOD 10ng/g, lower LOQ 33ng/g and upper LOQ 3333ng/g.

Intertek's Nitrosamine Impurity Analysis Services

Our GMP analytical team are experienced in providing analytical services according to FDA GC-MS, GC-MS/MS, LC-MS/MS and LC-HRMS methods, including performing the required method validations where the data can be used to support regulatory submissions or quality assessment of the API or drug product.

With scientists who are adept at method development and validation of suitable analytical procedures, we regularly help clients overcome the challenges of low detection levels, difficult matrices and identification of unknowns in the course of pharmaceutical impurities analysis. Additionally, we offer highly sensitive and specific method development and validation expertise to assess other carcinogenic or genotoxic impurities in drug products.

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

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

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    Visit www.intertek.com/pharmaceutical for more information.