Nitrosamines - Confirmatory Tests

Nitrosamines - Confirmatory Tests
Product Description

The screening test consists in the assessment of which nitrosamines are present in the drug product below an acceptable limit, defined according to the recommendations of EMA. 

These limits are calculated based on the acceptable intake (AI) of each nitrosamine. QPLAB has a LC-MS/MS method that includes up to 10 nitrosamines to a detection limit between 5-10 ppb.

Nitrosamine / AI (ng/day)

  • NDMA (62-75-9)  - 96.0
  • NDEA (55-18-5)  - 26.5
  • NMBA (61445-55-4) - 96.0
  • NEIPA (16339-04-1) - 26.5
  • NDIPA (601-77-4) - 26.5
  • NMPZ (16339-07-4) - 26.5
  • NMPA (614-00-6) - 34.3
  • NDBA (924-16-3) - 26.5
  • NDPA (621-64-7) - 26.5
  • NMOR (59-89-2) 127
  • NNV - 37

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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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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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