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Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?
how many types of balance calibration test?
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
What is the main difference between ODS1 and ODS2 Hplc column.
why does used dry caffien in HPLC calibration?
How doing qbd practically?
What is control room temperature and which guide line says?
What is mean by PDR?
How would you decide dissolution medium for NCE compound of class I drug
what are the guidelines for analytical method validations?
how to calibrate hplc & gc
How to do regeneration of Metacarb Pb plus column?
analytical method validation require to with respect to release specification or shelf life specification?
what is biorelivent dissolution media?
In BP2013, Loperamid HCl monograph. Assay by titration with 0.1N sodium hydroxide using hydrocloric acid 0.01N and reading the volume added between the 2 points of inflexion. I have a question that if the diluent solvent is ethanol is certainly consumed a amount of volume of titrant, so this volume must be eliminated on the result calculation or not apart from first point which is subtracted above.
