Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
October 15, 2025International journal of research and scientific innovationOpen Access

A Review on Synthesis and Biological Activities of Nitrosamine Impurities in Active Pharmaceutical Ingredients (APIs)

View Full Paper
Ask AI
Bookmark
Share

Authors

PDPrasadS DalviSSSharad S Sankhe

Discussion

Loading...

Member takes

Overview

This review discusses the formation of nitrosamine impurities in pharmaceuticals, highlighting their carcinogenic potential and analytical detection methods.

Key Points

  • Nitrosamine impurities formed during API manufacturing are carcinogenic and genotoxic, raising safety concerns.
  • Validated analytical methods like HPLC and GC are crucial for quantifying nitrosamine impurities effectively.
  • Understanding the synthesis of nitrosamines from secondary amines during manufacturing can help mitigate risks.
  • Identifying nitrosamine impurities involves highly sensitive techniques such as MS and NMR to ensure product safety.

Cite This Study

Dalvi et al. (2025) studied this question.

synapsesocial.com/papers/68efa18f9d05deea71d13e57https://doi.org/10.51244/ijrsi.2025.120800343
View Full Paper
Ask AI
Bookmark
Share

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1The Nitrite-Amines Nexus in Nitrosamine Formation: Mechanisms, Mutagenic Implications, Regulations, and Root Causes in Medicines2025
  2. 2Pharmaceutical Nitrosamines: A Comprehensive Review of Health Risks, Detection, Mitigation Strategies Supplemented with CYP450 Interactions as Molecular Simulations for Mechanistic Insight into Carcinogenicity2025 · 7 citations
  3. 3The clinical and regulatory status of NDSRI: A global imperative2024 · 3 citations
  4. 4A Review on Nitrosamines Impurities in Pharmaceuticals-From Contamination Sources to Analytical Determination2026
  5. 5The clinical and Regulatory Status of NDSRI: A Global Imperatisve2024