IFF Pharma Solutions, a specialist in polymer innovations, has announced the launch of Low Nitrite METHOCEL hydroxypropyl methylcellulose (HPMC), a range of low nitrite cellulose ethers developed to reduce the risk of nitrosamine formation in finished pharmaceutical dosages.
IFF Pharma Solutions
This product line addresses the industry’s concern with nitrosamine risk and mitigation strategies for their formation. Through enhanced process controls and industry-leading analytical science, IFF Pharma Solutions limits and measures the level of nitrite in every batch of Low Nitrite METHOCEL.
"METHOCEL HPMC is the polymer of choice for formulating both controlled release and immediate release pharmaceutical dosages," said Michael Baumann, global product manager, METHOCEL, IFF Pharma Solutions. "Low Nitrite METHOCEL is designed to meet the highest standards of quality and safety. These specialised grades, which provide the same reliability and performance as standard METHOCEL, help ensure minimal nitrite content, making them ideal for applications where low levels of nitrite are critical."
Effective in reducing nitrosamines in model formulations
Low Nitrite METHOCEL minimises the potential of nitrosamine formation and helps ensure finished drug products comply with stringent safety regulations, enhancing the overall quality of our customers' drug products.
Designed to meet the highest standards of quality and safety
Using validated 2D ion chromatography with mass spectrometry, and with high selectivity and sensitivity, every batch receives a nitrite test result on the certificate of analysis. Each batch of Low Nitrite METHOCEL is tested to ensure nitrite levels are consistently at or below 200 parts per billion.
A dependable solution backed by polymer expertise
To ensure the best performance for our customers' drug products, Low Nitrite METHOCEL provides reliable and consistent results. This is supported by our polymer expertise and problem-solving mindset across the entire drug development pipeline.