by maheshbhuva | Dec 4, 2025 | 21 CFR, Analytical Chemistry, Deviation, ICH Guideline, Quality control (QC)
1. EDQM / EU GMP (Europe) ​Focus: The European approach places heavy emphasis on the Qualified Person (QP). The QP acts as the gatekeeper and must personally ensure that any deviation does not violate the Marketing Authorization (MA). ​Risk Management: EU GMP...
by maheshbhuva | May 17, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, QMS, Quality control (QC), Wheat
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:”Specificity is the ability to assess unequivocally the analyte in the presence of components...
by maheshbhuva | May 18, 2023 | Hplc
Phosphate buffer Citrate buffer Formate buffer Acetate buffer Tris(hydrixymethyl) -aminomethane Phosphate buffer Pka 2.1 Ph range 1.1 tob3. 1 Pka 7.2 Ph range 6.2 to 8.3 Pk 12.3 Ph range 11.3 to 13.3 Citrate Pka 3.1 Ph range 2.1 to 4.1 Pka 4.7 Ph 3.7 to 5.7 Pka 5.4 Ph...
by maheshbhuva | Jan 8, 2023 | Analytical Chemistry, karl Fischer titration
Guide line935 USPType Karl Fischer titrationColoarimatry and volumetry titrationColarimatry titration because use of a electromagnetic filedVolumetric titrationThere is a manually titration (classical method like In burette fill kf reagent and conical flask fill a...
by maheshbhuva | Jan 6, 2023 | Analytical Chemistry, sulphate ash
Learn scientific techniques and practical tips and tricks, which will help you to improve the output of your experiment particular in Analytical chemistry, Organic chemistry, and physical chemistry Application download given link Sulphate Ash- (Wet lab Calculator)...
