by maheshbhuva | May 13, 2024 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC)
Type of analytical procedure validated Identification tests. Quantitative tests for impurities’ content. Limit tests for the control of impurities. Quantitative tests of the active moiety in samples of drug substance or drug product or other selected...
by maheshbhuva | May 4, 2024 | Hplc, Hplc column, Quality control (QC)
Theoretical Plates chromatography In chromatography, theoretical plates are a fundamental concept used to assess the separation efficiency of a chromatographic column. They play a crucial role in determining the quality and effectiveness of the chromatographic...
by maheshbhuva | Mar 31, 2024 | Analytical Chemistry, Analytical method development hplc,, Hplc, Hplc column, Quality control (QC)
In HPLC chromatography, the column is where the separation of the sample takes place. This is where the sample is passed through the stationary phase with the mobile phase, resulting in the separation of the sample components. As the sample being analyzed is likely to...
by maheshbhuva | Nov 3, 2023 | 21 CFR, Uncategorized
21 CFR stands for Title 21 of the Code of Federal Regulations. It is a set of regulations issued by the United States Food and Drug Administration (FDA) that covers various aspects of regulatory requirements for pharmaceuticals, medical devices, food, cosmetics, and...
