What Is Polymorphism and How Does It Impact Pharmaceutical Development
Learn what polymorphism is in pharmaceuticals, its types, real-world examples, testing methods, regulatory guidelines, and its impact on drug development, stability, and bioavailability
Essential HPLC Equations and Terminology Every Chromatographer Should Know
Essential HPLC equations and terminology encompass key parameters related to column separation, mobile and stationary phases, flow rate, retention time, and resolution. A clear understanding of these concepts is vital for accurate method development, optimisation, and reliable HPLC analysis. In this blog, I will discuss the fundamental HPLC terms and formulas that every chromatographer should […]
Classification of Regulatory Submissions in Pharma: From Discovery to Market
Regulatory submissions in the pharmaceutical industry are categorised by development stage, product type, and regulatory authority, including INDs, NDAs, ANDAs, DMFs, and the CTD/eCTD format. The development of a pharmaceutical product, from the lab bench to the pharmacy shelf, is a long, complex, and highly regulated process. To ensure safety, efficacy, and quality, pharmaceutical companies […]
Revalidation of Analytical Method: What It Is, How & When It’s Performed, and Why It Matters
Learn what analytical method revalidation is, when and how to perform it, and why it’s essential for ensuring accurate, compliant, and reliable lab results in regulated industries
Methanol vs. Acetonitrile In HPLC: Which Solvent is Better and Why?
Discover the key differences between methanol and acetonitrile in HPLC. Compare safety, cost, UV cut-off, resolution, peak shape, and more to determine the best solvent for your analysis.
Extractables and Leachables Impurities : Get Mastery With Interview FAQs
Learn what extractables and leachables are, how they differ, and how they are tested in the pharmaceutical industry.
Generic vs Branded Medicines: Why Generic Medicines Are Cheaper
Learn Generic vs Branded Medicines, definition, key differences, and why generic medicines are cheaper with FAQs
HPLC Column Washing by Sonication: When, Why, and How?
HPLC Column Washing by Sonication is used to remove strongly adsorbed materials and improve column performance HPLC columns can be cleaned effectively using sonication, a process that uses ultrasound waves to help remove built-up contaminants. This method is especially helpful for getting rid of strongly adsorbed substances that regular flushing might miss. To clean the […]
Risk Assessment in Pharma: 5 Key Methods, Case Study & FAQs
Learn about risk assessment in pharma, including 5 key methods, how they’re used in drug development, and how they help ensure product safety, regulatory compliance, and quality
Process Validation In Pharmaceutical: Principles, Types, Case Studies And FAQs
Learn about process validation in the pharmaceutical industry, its principles, types, and key case studies. Understand its importance for ensuring product quality, regulatory compliance, and patient safety.