Quality Management System
by A quality management system (QMS) is a collection of business processes and procedures which aims to ensure that the quality of products or services meets …
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System Suitability in HPLC Analysis
HPLC chromatographic technique is used in pharmaceutical industries for analysis. System suitability testing limits are acceptance criteria that must met before starting the analysis. There …
MACO and NOEL Calculation for Cleaning Validation
MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO is a “Maximum allowable carryover”. …
UV-Visible Spectroscopy
Ultraviolet-visible (UV-Vis) spectroscopy is a widely used technique in many areas of science ranging from bacterial culturing, drug identification and nucleic acid purity checks and quantitation, …
Detectors for Chromatography
What are detectors in chromatography A chromatography detector is a device used in GC or LC to detect components of the mixture being eluted off the chromatography column. There …
Gas chromatography
Gas chromatography (GC) is an analytical technique used to separate and detect the chemical components of a sample mixture to determine their presence or absence and/or …
Cleaning Validation
What is cleaning Validation Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive …
Forced Degradation
The FDA and ICH the requirement of stability testing data to understand how the quality of a drug substance and drug product changes with time …
ELSD Detector
An evaporative light scattering detector (ELSD) is a detector used in conjunction with high-performance liquid chromatography (HPLC), Ultra high-performance liquid chromatography (UHPLC), Purification liquid chromatography such as …
RI Detector
RI detectors monitor the difference in RI between the column eluent containing analyte and a reference stream containing mobile phase only. These detectors are the closest …