Product Description
Experience a grand, premier solution for nitrosamines detection with our in-demand Nitrosamines Impurities Testing by LCMS. Explore the cutting-edge LC-MS/MS validated method that identifies even trace nitrosamines as low as 0.03 ng/mLensuring compliance with strict USFDA, EMA, and ICH M7 standards. Designed for batch analysis with high throughput, this service covers NDMA, NDEA, NMBA, and more. Last chance to secure ravishing accuracy (typically >95%) and reporting within 3-7 working days for your pharmaceutical samples and APIs. Depend on our automated, digital, and compliant laboratory in India.
Grand Performance & Extra Features
Our Nitrosamines Impurities Testing delivers premier accuracy, using automated LC-MS/MS systems for detailed quantification from ppb to ppm. Supporting high sample throughput and batch analysis, the interface with PC workstations provides seamless, digital data output. Sample requirements are minimal (1-2 mL), with ambient temperature processing and instrument-driven analytics. The method ensures exceptional reliability, covering tablets, capsules, APIs, and bulk substances to meet rigorous regulatory demands across diverse pharmaceutical formats.
Main Export Market & Voluminous Supply
We cater to a broad export market spanning India and global clientele, assured with certifications under USFDA, EMA, and ICH M7 guidelines. Supply ability is robust, upholding swift batch analysis and quick dispatch for your pharmaceutical needs. Our structured outlay enables timely delivery and comprehensive reporting, empowering partners worldwide to maintain compliance. Leverage our certified, resourceful services for reliable nitrosamine impurity analysis, ensuring safety and regulatory peace of mind.
FAQs of Nitrosamines Impurities Testing by LCMS:
Q: How is nitrosamines impurities testing conducted with your LCMS system?
A: Testing is performed using a validated LC-MS/MS method with internal standard calibration, allowing highly sensitive and accurate detection of regulated nitrosamines in pharmaceutical samples.
Q: What sample types are accepted for nitrosamines impurities analysis?
A: We can process a variety of sample types including tablets, capsules, active pharmaceutical ingredients (APIs), and bulk pharmaceuticals.
Q: When can I expect to receive the detailed analytical report?
A: A comprehensive report is typically provided within 3 to 7 working days after submission and acceptance of your sample.
Q: Where is the testing conducted and what assurance of compliance is given?
A: Testing is conducted in a certified laboratory in India, adhering to USFDA, EMA, and ICH M7 guidelines, ensuring the highest standard of regulatory compliance.
Q: What are the benefits of using LCMS-based nitrosamines testing for my pharmaceutical products?
A: You gain reliable detection at extremely low concentrations, rapid turnaround, regulatory compliance assurance, and precise quantification across a range of nitrosamines.
Q: How much sample volume is required for testing?
A: Typically, 1-2 mL of the test sample is required for accurate analysis, depending on the protocol and matrix of the sample.
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