Nitrosamines: Pharmaceutical Impurities, Genotoxicity and Drug Safety

Category: Science & Technology → Pharmaceuticals → Public Health

Why in News?

In August 2026, the Indian Pharmacopoeia Commission launched seven nitrosamine impurity reference standards for pharmaceutical quality testing.

What Are Nitrosamines?

Nitrosamines are chemical compounds that can occur as impurities in pharmaceutical products.

Some nitrosamines are:

  • Highly potent
  • Genotoxic
  • Carcinogenic

How Can They Arise?

They may form unintentionally during:

  • Drug manufacturing
  • Storage
  • Packaging
  • Chemical reactions involving certain ingredients
  • Contamination

Examples of IPC Reference Standards

The seven standards launched included:

  • NDMA
  • NDEA
  • NEIPA
  • NDBA
  • NMPA
  • NDIPA
  • NMBA

Why Important?

Nitrosamine contamination has been associated with concerns involving medicines used for:

  • Hypertension
  • Gastric disorders
  • Diabetes
  • Tuberculosis

Key Pointers

  • Nitrosamines → Pharmaceutical impurities
  • Major concern → Genotoxicity + carcinogenicity
  • Indian agency → Indian Pharmacopoeia Commission
  • 2026 development → Seven reference standards
  • Purpose → Detection, quantification and quality assurance