1st Mena Lab accredited by USFDA-LAAF program, specialized in wide range of analysis,
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Pharmaceutical analysis
At our cutting-edge laboratory, we provide an extensive array of testing services tailored for the pharmaceutical industry. Our offerings include comprehensive impurities analysis, advanced molecular testing, and nitrosamine detection, utilizing the most sophisticated and reliable instruments available. Our nitrosamine detection is particularly crucial, given the significant health concerns associated with these probable human carcinogens.
We employ state-of-the-art techniques such as Liquid Chromatography-Mass Spectrometry (LC-MS/MS), Gas Chromatography-Mass Spectrometry (GC-MS), and other instruments, to ensure the most accurate and sensitive detection of nitrosamines and other impurities. Additionally, our molecular testing capabilities allow for precise examination of genetic and molecular components, ensuring the purity and safety of pharmaceutical products.
Our commitment to excellence ensures that all pharmaceutical products we test meet the highest standards of quality and safety. By leveraging our advanced technology and expert knowledge, we deliver precise and trustworthy results that support the pharmaceutical sector's stringent regulatory requirements. Our comprehensive testing services are designed to help our clients ensure the safety, efficacy, and regulatory compliance of their products.
Nitrosamines in Pharmaceuticals:
We are proud to say that Nitrosamines testing is available at our laboratory, using LCMS/MS.
Nitrosamines are chemical compounds classified as probable human carcinogens based on animal studies. They can form during the manufacturing process of pharmaceuticals, often as a result of the reaction between secondary amines and nitrites under acidic conditions. The presence of nitrosamines in medicines became a significant public health concern in 2018 when they were detected in certain blood pressure medications, such as Valsartan. Regulatory agencies like the FDA and EMA have since issued guidelines to limit these impurities due to their potential carcinogenic risks. Ensuring the absence or minimal presence of nitrosamines in pharmaceuticals is crucial for patient safety.
Announcement اعلان هام
Environmental laboratory is now part of Nexalab research center.
All needed information regarding the environmental lab will remain the same in the mean time.
مختبر البيئة اصبح جزء من نيكسالاب للابحاث, كل ما تريدون معرفته عن مختبر البيئة لازال كما هو في الوقت الحالي.
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