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 | Mar 16, 2023 | ALCOA++, Analytical Chemistry, QMS
Attributable Mainly to ask of following question is that Who, when, what and why? Who Person has identified When place has identified What event identified Why mean why all the operation will be happen that all example will give as on QMS activity document other...
by maheshbhuva | Mar 9, 2023 | Method validation
Specificity As per ICH Q2A guideline defined as Specificity is the ability to assess unequivocally analyte in the present of component which may expected to present. Typically these might include impuries, degradants, matrix etc Selectivity The extent to which the...
by maheshbhuva | Mar 5, 2023 | Molarity
Definition Molecular weight dissolved in 1000 ml solution called Molarity Molarity Noted: M Formula Molarity We have make 1M NaOH for 300 ml water 12 gram NaOH dissolve in 1000 ml water If for use liquid (example Use formula Density = M/V (Mass /Volume) Eg For...
