Bridging Study: Comparing QQQ and HRMS for Impurity X Quantitation, determining their regulatory alignment, and evaluating method transfer feasibility
In pharmaceutical analysis, selecting the right instrumentation is critical for ensuring precise and regulatory-compliant impurity quantitation. At Emery Pharma, we…
An Overview of Nitrosated Drug Substance Related Impurities (NDSRIs)
Nitrosamines in Drug Substance (DS) In 2018 health authorities became aware of the nitrosamine N-nitrosodimethylamine (NDMA) in valsartan drug substance.…
The Critical Role of Bioanalytical Platform Selection: Ligand-Binding Assays vs Mass Spectrometry
The selection of a bioanalytical platform is critical because it directly influences the accuracy, sensitivity, and specificity of the data…
Countdown to Compliance: The August 2025 Deadline for NDSRI Testing Looms Over Pharmaceutical Industry
As the pharmaceutical industry approaches the crucial deadline of August 2025, manufacturers of both currently marketed and newly approved drug…
Antimicrobial Textiles Testing
Humans have been weaving textiles and fashioning clothing from fabrics for thousands of years, but one of the great challenges…
Ensuring Quality and Efficacy of GLP-1 Agonists: Analytical Challenges and Solutions in Therapeutic Peptide Production
Glucagon-like peptide-1 (GLP-1) agonists represent an exciting class of drugs that have gained significant attention in recent years for their…
Antibody Drug Conjugates Q&A: A Novel Approach to Drug Delivery in Oncology
What is an antibody drug conjugate? An antibody drug conjugate (ADC) is an innovative drug modality that consists of three…
Native Mass Spectrometry (Native-MS) for Aggregate and Charge Variant Analysis
Size exclusion chromatography (SEC) and ion exchange chromatography (IEX) are traditional methods utilized for characterizing biotherapeutics under non-denaturing conditions. The…
A Guide to Quantitative NMR (qNMR)
Quantitative NMR (qNMR) stands as a robust method for gauging pharmaceutical purity. In the realm of analytical chemistry, nuclear magnetic…
The Past, Present and Future of ADCs
ADCs, short for antibody-drug conjugates, consist of three essential components: a monoclonal antibody (mAb), a linker molecule, and a small…