Nitrosamine Impurities Testing

Nitrosamine Impurities Testing
Product Description

Nitrosamine impurities pose a great risk since they are most likely carcinogenic to humans. Nitrosamines are compounds formed from the reaction of a nitroso group with an amine. Nitrosamines are produced during the interaction of secondary amines, amides, carbamates, urea derivatives, nitrites, or other nitrogenous agents with nitrogen in a +3 state.

Guideline ICH M7 (R1) categorizes nitrosamines as class 1 “known mutagenic carcinogenic” impurities. All processes that involve the use of nitrites and secondary, tertiary, and quaternary amines are prone to the formation of nitrosamine impurities.

Chromak Research Inc.

  • Country/Region:
    United States
  • On CPHI since:
    2026
  • Certificates:
    2
  • Employees:
    1 - 24
Company types
Contract Research Organisation (CRO)
Primary activities
Analytical Services
Laboratory Services
Specifications
  • Supplied from
    United States

Chromak Research Inc.

  • Country/Region:
    United States
  • On CPHI since:
    2026
  • Certificates:
    2
  • Employees:
    1 - 24
Company types
Contract Research Organisation (CRO)
Primary activities
Analytical Services
Laboratory Services

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