Chiral HPLC Analysis – Chiralpedia

Episode 5: Defending the Method: Regulatory Expectations and Where the Field Is Heading

Leave a Comment / Chiral Chromatography, Chiral HPLC Analysis, Chiral science / By Valliappan Kannappan and Chandramouli R / #chirality, #chiralpedia / August 22, 2026 August 22, 2026

How chiral methods and isolated standards are justified in a dossier, and a calibrated view of the future The regulatory position on stereochemical purity Regulators have treated stereochemistry as a quality and development issue for decades, and the core position has been stable even as the vocabulary evolved. FDA’s 1992 stereoisomer guidance requires that the …

Episode 5: Defending the Method: Regulatory Expectations and Where the Field Is Heading Read More »

Episode 4: From Peak to Standard: Preparative Isolation of Chiral Impurities

Leave a Comment / Chiral Chromatography, Chiral HPLC Analysis, Chiral science / By Valliappan Kannappan and Chandramouli R / #chiral_chromatography, #chirality, #chiralpedia / August 19, 2026 August 19, 2026

“Turning an analytical separation into an isolated, characterised, defensible impurity standard” Why isolate a chiral impurity at all Analytical scientists ask for isolated chiral impurities when a chromatogram is no longer enough. The reasons are concrete: structural elucidation of an unknown peak, preparation of a reference standard, response-factor determination, qualification under ICH impurity expectations, forced-degradation …

Episode 4: From Peak to Standard: Preparative Isolation of Chiral Impurities Read More »

Episode 3: State of the Art: Selectors, SFC, Speed, and Sensible Automation

Leave a Comment / Chiral Chromatography, Chiral HPLC Analysis, Chiral science / By Valliappan Kannappan and Chandramouli R / #chiral_chromatography, #chiral_HPLC_analysis, #chirality, #chiralpedia / August 13, 2026 August 13, 2026

What modern chiral separation science can do now, and where the honest limits still lie The present technology landscape The most useful framing of the current landscape is that it is no longer sensible to ask, in the abstract, whether chiral HPLC or chiral SFC is “the best” approach. Modern laboratories operate with both, or …

Episode 3: State of the Art: Selectors, SFC, Speed, and Sensible Automation Read More »

Episode 2: Developing a Chiral HPLC Method: A Structure-Led Workflow

Leave a Comment / Chiral Chromatography, Chiral HPLC Analysis, Chiral science / By Valliappan Kannappan and Chandramouli R / #chiral_chromatography, #chiral_method_development, #chirality, #chiralpedia / August 8, 2026 August 8, 2026

From a structural diagnosis of the analyte to a defendable, robust, lifecycle-ready method Start with the molecule, not the column catalogue A credible chiral method does not begin with random column screening. It begins with a short structural diagnosis of the analyte and the likely impurity set. The pKa values indicate whether the analyte is …

Episode 2: Developing a Chiral HPLC Method: A Structure-Led Workflow Read More »

Episode 1: Why Chirality Still Matters: Stereochemistry as a Critical Quality Attribute

Leave a Comment / Chiral HPLC Analysis, Chiral science, Chiral Separation, Chirality / By Valliappan Kannappan and Chandramouli R / #chiral_chromatography, #chiral_method-development, #chirality, #chiralpedia / August 2, 2026 August 2, 2026

The pharmaceutical meaning of chirality, the real impurity space, and where chiral HPLC fits The pharmaceutical meaning of chirality Chirality matters in drug development for a simple reason. Biological systems are chiral, so the body does not experience two stereoisomers as the same molecule. FDA stated this explicitly in its landmark 1992 stereoisomer guidance, noting …

Episode 1: Why Chirality Still Matters: Stereochemistry as a Critical Quality Attribute Read More »