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HPLC has many applications in both laboratory and clinical science. It is a common technique used in pharmaceutical development, as it is a dependable way to obtain and ensure product purity. [59] While HPLC can produce extremely high quality (pure) products, it is not always the primary method used in the production of bulk drug materials. [60]
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
In analytical chemistry, cross-validation is an approach by which the sets of scientific data generated using two or more methods are critically assessed. [1] The cross-validation can be categorized as either method validation [ 1 ] or analytical data validation.
A calibration curve plot showing limit of detection (LOD), limit of quantification (LOQ), dynamic range, and limit of linearity (LOL).. In analytical chemistry, a calibration curve, also known as a standard curve, is a general method for determining the concentration of a substance in an unknown sample by comparing the unknown to a set of standard samples of known concentration. [1]
Validation and Quality Control: It is important to ensure the accuracy and reliability of the integration process, by performing validation and quality control checks to the software itself. This may involve comparing integration results with known standards, replicating analyses, and assessing precision and accuracy [ 6 ]
Her collaborative effort with GSK colleagues in 2003 outlined the development and validation of a rapid gradient HPLC method for determining Human Serum Albumin (HSA) binding of discovery compounds. [9] In 2011, she proposed a novel approach, using calibrated HPLC retention times on biomimetic stationary phases to develop mechanistic models.
Silica gel particles are commonly used as a stationary phase in high-performance liquid chromatography (HPLC) for several reasons, [13] [14] including: High surface area: Silica gel particles have a high surface area, allowing direct interactions with solutes or after bonding of variety of ligands for versatile interactions with the sample molecules, leading to better separations.
Small scale chromatography columns are mostly intended for design of experiments (DoE); proof of concept; validation (drug manufacture) or research and development experiments. Columns of this scale category are distinguished by their small dimensions in comparison to chromatography columns intended for larger scales as well as relatively high ...
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