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Portal:Analytical chemistry
How a purity number is produced, and what it means
Introduction
Almost every quality dispute in this field reduces to a question about an analytical result: what was measured, against what standard, by what method, and what the number is relative to. This portal covers separation science, mass spectrometry, the compendial water and endotoxin tests, and the validation framework that decides whether a method is fit for the claim being made from it.
The single most useful idea here is the distinction between area percent purity and peptide content: the first is a ratio among the species that eluted, the second is a mass fraction of the vial.
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Selected article
Area percent purity — Area percent purity is the area of the principal chromatographic peak as a proportion of total integrated peak area. It is a relative measure and says nothing about the mass in a vial.
37 revisions since 26 August 2024. Discussion · history
Articles in this portal
- Area percent purity
- High-performance liquid chromatography
- Liquid chromatography-mass spectrometry
- Retention time
- Reverse-phase HPLC
- Electrospray ionisation
- Mass spectrometry
- Amino acid analysis
- Analytical method validation
- Bacterial endotoxin test
- Janoshik Analytical
- Karl Fischer titration
- Limit of detection
- Loss on drying
- Peptide content
- Sterility testing
- Bacteriostatic water
- Residual solvent
- Sterile water for injection
- USP General Chapter 71
- USP General Chapter 85
- Vial
- Purity claim inflation
- Reference standard
Things you can do
- Source the interference claims in the water-determination articles individually.
- Add a worked limit-of-detection calculation with real signal-to-noise figures.
- Reconcile the peak-purity terminology used across the chromatography articles.
Items here are deliberately small enough to finish in one sitting. See Project:Verifiability before adding sources.
Categories feeding this portal
- Chromatography (5)
- Mass spectrometry (3)
- Analytical methods (16)
- Compendial testing (11)
- Method validation (4)
- Reference standards (2)