ICH Guideline

OOS- Out of Specification Investigation – Interview Question and Answer

Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab…

3 years ago

According USP Chapter 621 : Adjustment of Mobile Phase

Adjustment of Mobile Phase Adjustment in composition of the mobile phase Adjustment ph of the aqueous component of the mobile…

3 years ago

(621) USP CHAPTER FOR CHROMATOGRAPHY

All chapter are use full for ADJUSTMENT of chromatography, TLC etc  In such case some questions arias that Why adjustment…

3 years ago

HPLC Calibration As per IPC Pharmacopeia give guidance

HPLC Calibration we have perform as earlier as per protocol Company will provided Like example  Shimanzu HPLC calibration will perform…

3 years ago

Specificity in analytical method validation – type of interference

Specificity As per ICH Q2A guideline defined as Specificity is the ability to assess  unequivocally analyte in the present of…

3 years ago

Molarity – Definition, Formula, calculation example

Definition Molecular  weight dissolved in 1000 ml solution called Molarity Molarity Noted:  M Formula Molarity We have make 1M NaOH…

3 years ago

Analyst do some most common error ? How care and prevent QMS activity

Wet Lab analyst do Error ! Wet lab analyst are forgot a taken out of LOD or sulphated Ash, weight…

3 years ago

Guideline value- ICH Q1A for stability study

Guideline value- ICH Q1A for stability study

3 years ago

Interview questions and answers karl Fischer titration

Guide line935 USPType Karl Fischer titrationColoarimatry and volumetry titrationColarimatry titration because use of a electromagnetic filedVolumetric titrationThere is a manually…

3 years ago

Why only Water & Sodium Tatrate Is Use For Calibration Of Karl Fischer Titrator?

DST is primary standard and it is stable up to 150 degree Centigrade. It release free water molecules easily when…

3 years ago