Intervein Research Labs which is USFDA approved analytical services provider from Ahmedabad, Gujarat India.
- 1) Following the identification of nitrosamines in pharmaceutical products, the US Food and Drug Administration (US FDA) and the European Medical Agency (EMA) have released specific requirements and limitations for nitrosamine contaminants.
- 2) We have the capability to detect nitrosamine impurities in your pharmaceutical products, verify compliance, and guarantee both product and patient safety.
- 3) We specialize in developing customized test methods, based on LC-MSMS, to detect the presence of nitrosamine traces in drug products, raw materials, and active pharmaceutical ingredients (APIs) at recommended LOD/LOQ levels and specifications.
- 4) Our methods are capable of simultaneous screening of multiple nitrosamines within the same sample or can be applied as targeted analyses for one or two specific contaminants. The use of cold-labeled internal standards ensures highly accurate quantitation even in the most complex matrices.
- Nitrosamine impurities testing enables you to:
- 1) Regulatory agencies strongly advise all manufacturers and providers to conduct thorough product testing in order to safeguard patients and to implement robust measures to prevent impurities from occurring in medications.
- 2)Detecting and measuring nitrosamine residues in drug products, raw materials, active pharmaceutical ingredients (APIs), and packaging is vital for ensuring the safety of our products and safeguarding the well-being of patients.
- 3) This testing is indispensable for validating regulatory compliance and refining extraction methods to achieve the necessary levels of Limit of Detection (LOD) and Limit of Quantitation (LOQ) in drug products.
- 4) Moreover, it entails conducting method development, transfer, validation, and batch release to maintain superior quality standards.