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In today’s competitive pharmaceutical landscape, ensuring product quality is paramount. As regulatory demands continue to evolve, the significance of rigorous testing methods cannot be overstated. Welcome to ‘Unlocking Quality: The Ultimate Guide to GMP NMR Testing and Analytical Method Development,…
In the fast-paced world of drug development, bioanalysis plays a crucial role in determining a drug’s pharmacokinetics (PK) and pharmacodynamics (PD). At Emery Pharma, we specialize in providing high-quality bioanalytical services to support pharmaceutical and biotechnology companies at every stage…
In pharmaceutical analysis, selecting the right instrumentation is critical for ensuring precise and regulatory-compliant impurity quantitation. At Emery Pharma, we conducted a bridging study to compare two mass spectrometry techniques—Triple Quadrupole Mass Spectrometry (QQQ) and High-Resolution Mass Spectrometry (HRMS)—for the…
Nitrosamines in Drug Substance (DS) In 2018 health authorities became aware of the nitrosamine N-nitrosodimethylamine (NDMA) in valsartan drug substance. The investigations expanded, NDMA and other potent nitrosamines were found in the more drugs in sartan family. In late 2019,…
As the pharmaceutical industry approaches the crucial deadline of August 2025, manufacturers of both currently marketed and newly approved drug products are under increasing pressure to evaluate and control the levels of Nitrosamine Drug Substance-Related Impurities (NDSRIs) in their products.…
Glucagon-like peptide-1 (GLP-1) agonists represent an exciting class of drugs that have gained significant attention in recent years for their potential to treat type 2 diabetes mellitus (T2DM) and obesity. These medications are a form of therapeutic peptide that mimics…
Quantitative NMR (qNMR) stands as a robust method for gauging pharmaceutical purity. In the realm of analytical chemistry, nuclear magnetic resonance (NMR) spectroscopy emerges as a potent technique, offering insights into the structure, dynamics, and interactions of organic molecules while…
Method development and validation are essential components of drug development and chemistry, manufacturing, and controls (CMC). The goal of method development and validation is to ensure that the methods used to measure the identity, purity, potency, and stability of drugs…
Emery Pharma presented this work at the 68th American Society for Mass Spectrometry (ASMS) Conference in June, 2020. Here, in this video, we presented the overview of the method for trace-level quantitative analysis of Poloxamers in biological samples by High-Performance…
Emery Pharma presented this work at the 68th American Society for Mass Spectrometry (ASMS) Conference in June 2020. Ranitidine, an H2 histamine receptor blocker, is extensively used for heartburn and other stomach acid-related diseases. Recently, the detection of the probable…