Nitrosamines - Quantitive Quality Control

Nitrosamines - Quantitive Quality Control
Product Description

LC-MS/MS methods are nowadays commonly used for nitrosamines analysis in all types of materials, since it allows analyte-specific detection based on both retention time and structurally specific fragmentation information in conjunction with high sensitivity.

After the establishment of the nitrosamines limits, the quantification limit of QPLAB´s method can be adapted to the product under analysis, ensuring that the method has the necessary sensitivity to control the impurity content.

QPLab has in-house methods to determine nitrosamines based on the acceptable intake (AI) of each nitrosamine:

  • NDMA (62-75-9) - 96.0 ng/day
  • NDEA (55-18-5) - 26.5 ng/day
  • NMBA (61445-55-4) - 96.0 ng/day
  • NEIPA (16339-04-1) - 26.5 ng/day
  • NDIPA (601-77-4) - 26.5 ng/day
  • NMPZ (16339-07-4) - 26.5 ng/day
  • NMPA (614-00-6) - 34.3 ng/day
  • NDBA (924-16-3) - 26.5 ng/day
  • NDPA (621-64-7) - 26.5 ng/day
  • NMOR (59-89-2) 127.0  ng/day
  • NNV - 37.0  ng/day

Validation of a quantification method

The validation of a quantitative method for the determination of N-nitrosamines impurities in drug products will be carried out according to ICH guidelines.

Routine QC analysis

Routine analysis of each sample / batch will be performed according to the validated method.

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QpLab - Pharma Services, Lda

  • PT
  • 2019
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Service
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Specifications
  • Supplied from
    Portugal
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QpLab - Pharma Services, Lda

  • PT
  • 2019
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Service
View company profile

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