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Quality Control Bolg
Out of specification Investigation Step in pharmaceutical
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...
Which is best solvent between Methanol vs Acetonitrile in HPLC
analytical method validation for pharmaceutical quality control
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 component(s) in...
Theoretical Plates chromatography-analytical chemistry
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...
Type of HPLC column
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...
21 cfr
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...