Understanding the Risks Associated with Nitrosamines
Nitrosamines have become a major concern in the pharmaceutical industry since their detection in certain medications. These chemical compounds, potentially carcinogenic, can form during the manufacturing of drugs. Facing these challenges, Armor Pharma is committed to minimizing these risks through rigorous methods.
The term “nitrosamine” refers to a class of compounds characterized by a chemical structure featuring a nitroso group attached to an amine. Nitrosamines typically form through a reaction involving three factors: amines from APIs, nitrosating agents (such as nitrites and nitrates), and favorable conditions (water, heat, acidity…).
Why It Matters
The safety of medications is crucial for public health. By taking proactive measures against nitrosamines, Armor Pharma demonstrates its commitment to the quality and safety of its products.
Armor Pharma’s Commitment
Armor Pharma, as a supplier of pharmaceutical grade lactose, implements strategies to combat the risks associated with nitrosamines:
- Evaluation of Nitrosamine Impurities: Our manufacturing processes are assessed with respect to eight nitrosamine impurities (NDEA, NDMA, NMBA, NMEA, NIEA, NDIA, NDBA, and NDPA). N-nitrosamines are formed by nitrosation of secondary amines and some tertiary amines.
- Exclusion of Nitrosating Agents: We never use secondary amines, nitrite and nitrate salts, or other nitrosating agents in our manufacturing processes.
- No use of solvents: We confirm that no solvents other than water are used, thereby eliminating the risk of cross-contamination
- Dedicated equipment: We confirm the use of dedicated equipment, thereby eliminating the risk of cross-contamination
- Absence of Nitrosamine Formation: Based on our evaluation, we can exclude the presence and formation of nitrosamine by-products in our excipients.
- Development of a Quantification Method: In collaboration with EUROFINS France, we have developed a selective method capable of quantifying nitrite levels as low as 30 ppb in our lactose grades. The initial results are very encouraging, showing levels below 50 ppb, further reinforcing our ability to guarantee the safety of our products.
Nitrosamines represent a significant challenge for the pharmaceutical industry, but with concerted efforts, we can minimize these risks. Armor Pharma is proud to contribute to this mission by ensuring safe and high-quality pharmaceutical grade lactose.
For further information on nitrosamines and our products, please do not hesitate to contact our Armor Pharma teams.
Sources:
Science Direct: Nitrosamines crisis in pharmaceuticals − Insights on toxicological implications, root causes and risk assessment: A systematic review - ScienceDirect National library of Medicine: Analytical Methodologies to Detect N‑Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices - PMC
