Search results
Results From The WOW.Com Content Network
The basic methods of separation in HPLC rely on a mobile phase (water, organic solvents, etc.) being passed through a stationary phase (particulate silica packings, monoliths, etc.) in a closed environment (column); the differences in reactivity among the solvent of interest and the mobile and stationary phases distinguish compounds from one ...
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.
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.
Analytical method validation; Computer system validation; Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following: Design qualification (DQ) Component qualification (CQ) Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ)
Liquid chromatography is a method of physical separation in which the components of a liquid mixture are distributed between two immiscible phases, i.e., stationary and mobile. The practice of LC can be divided into five categories, i.e., adsorption chromatography , partition chromatography , ion-exchange chromatography , size-exclusion ...
It aims to ensure that all levels of production are controlled and regulated. Deviations from prescribed output methods and final product irregularities are flagged by a process analytics database system. The FDA requires production data be recorded (FDA requirements (§ 211.180(e)). Continued process verification is stage 3 of process validation.
Hydrophilic interaction chromatography (or hydrophilic interaction liquid chromatography, HILIC) [1] is a variant of normal phase liquid chromatography that partly overlaps with other chromatographic applications such as ion chromatography and reversed phase liquid chromatography.