Nitrosamines
Tentamus Pharma & Med offers precise nitrosamine analysis according to international standards.
What are nitrosamines?
Nitrosamines are formed by the reaction of nitrites with secondary amines and are among the most critical impurities in pharmaceutical active ingredients and drugs. The presence of nitrosamines in pharmaceuticals has led to recalls worldwide in recent years and presented pharmaceutical companies with new challenges.
As a leading laboratory in the field of pharmaceutical analysis, Tentamus Pharma & Med specializes in identifying nitrosamines at all stages of drug manufacturing – from raw material testing to final product inspection. Our specialized nitrosamine analysis offers you a reliable, highly sensitive, and regulatory-compliant solution for identifying and quantifying these substances at trace levels.
By employing state-of-the-art LC-MS/MS and GC-MS/MS technologies, we achieve detection limits in the low ppb range and ensure the precise determination of both known and potentially emerging nitrosamines. Our method development is based on current guidelines (including ICH, EMA, FDA) and is individually tailored to your matrix, your active ingredient and your manufacturing processes.
Analysis of
Nitrosamines
RESPONSIBILITY AND EXPERTISE
We utilize state-of-the-art chromatographic techniques, such as gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS), to enable the precise identification and quantification of nitrosamine concentrations.
We support you throughout the entire product lifecycle.
Our services include:
- Risk assessment and screening of starting materials, intermediates, and finished medicinal products
- Development, optimization, and validation of robust analytical methods
- Routine analysis under GMP conditions
- Support with regulatory inquiries and submissions
Why Tentamus Pharma?
Our laboratories are equipped with cutting-edge technologies for the precise and efficient detection of nitrosamines.
Our laboratory managers and chemists specialize in nitrosamine analysis and offer expert advice and customized solutions.
Tentamus Pharma & Med complies with all international standards and regulations, providing you with reliable and legally compliant results.
Using high-resolution LC-MS/MS methods, we enable the detection of nitrosamines at trace levels. Our analytical services meet the strictest regulatory requirements and provide reliable data for your risk assessment and release processes.
Contact us today to learn more about our nitrosamine analysis.