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 | 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...
by maheshbhuva | Apr 5, 2023 | 621 USP CHAPTER, Analytical Chemistry
All chapter are use full for ADJUSTMENT of chromatography, TLC etc In such case some questions arias that Why adjustment in chromatography ? How adjustment justified ? Adjust chromatography If your method is validated and method are submitted in DMF so...
by maheshbhuva | Mar 24, 2023 | Hplc
HPLC Calibration we have perform as earlier as per protocol Company will provided Like example Shimanzu HPLC calibration will perform as per that guidance’s But now a day In 16th September 2021 As per IPC Pharmacopeia give guidance(Document ID IPC/GD/05) HPLC...
by maheshbhuva | Feb 6, 2023 | Analytical Chemistry, Deviation, Documents error (DIN), Pharmaceutical interview,, QMS
Wet Lab analyst do Error ! Wet lab analyst are forgot a taken out of LOD or sulphated Ash, weight forgotten, etc ! . Some dilution error !. Weight print are not past in work sheet OR analytical work report or protocol etc (whatever terminology used). ! Calibration...
