by maheshbhuva | Jun 1, 2024 | Analytical Chemistry, Out of specification, Quality control (QC)
Scope Input Martial In process stage Finish product Stability Note : Not applied in process stage which give procedure Further operation (e.g like give option in BMR if result not found as per Limit and further go operation e.g CF drying sample) Purpose: Ensure that...
by maheshbhuva | May 16, 2024 | Analytical Chemistry, Hplc, Quality control (QC)
Share this: Click to share on Facebook (Opens in new window) Facebook Click to email a link to a friend (Opens in new window) Email Click to share on Reddit (Opens in new window) Reddit More Click to share on X (Opens in new window) X Click to share on LinkedIn (Opens...
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...
