Validations: Analytical Methods, Limits & Confirmatory Testing
Calibration Curves & LOQ: Linear vs Weighted Fits Calibration Curves & LOQ: Linear vs Weighted Fits Introduction to Calibration Curves in Analytical Methods Calibration curves are foundational components in analytical and bioanalytical chemistry, crucial for quantifying the concentration of analytes in a variety of sample matrices. In pharmaceutical applications, particularly within the context of nitrosamine risk assessment, calibration curves inform…
System Suitability for Nitrosamine Methods The emergence of nitrosamines in pharmaceutical products has prompted a rigorous response from regulatory agencies such as the US FDA, EMA, and MHRA. This article focuses on the systematic assessment of analytical methods specifically designed to quantify nitrosamines, highlighting the necessity of establishing system suitability parameters for robustness and compliance. By adhering to the guidelines…
Analytical Strategies for Nitrosamines: LC-MS/MS vs GC-MS Analytical Strategies for Nitrosamines: LC-MS/MS vs GC-MS In recent years, the discovery of nitrosamines in pharmaceutical products has raised significant concerns among regulatory authorities and pharmaceutical manufacturers. Addressing these concerns requires a robust approach to risk assessment and control strategies. This article aims to provide a comprehensive guide on the analytical methods used…
Method Sensitivity vs Limits: NDMA and NDEA Detection Targets Method Sensitivity vs Limits: NDMA and NDEA Detection Targets The growing concern surrounding nitrosamines in pharmaceuticals has led to an increase in regulatory scrutiny and the need for robust analytical methods to assess their presence and quantification. Among the most prominent nitrosamines affecting pharmaceutical products are N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)….
Surrogate Standards and Isotopically Labeled IS: When and How Surrogate Standards and Isotopically Labeled IS: When and How Introduction to Surrogate Standards and Isotopically Labeled Internal Standards The pharmaceutical industry is facing increasing scrutiny regarding nitrosamine contaminants in drug products, particularly those containing active pharmaceutical ingredients (APIs) that may incorporate nitrosamines during manufacturing. As regulatory boundaries tighten globally, effective nitrosamine…