In case of dissolution test, if there is variation within 6
individual units however the batch is complying as per S1
criteria, is it necessary to do investigation for the same?
What should be the criteria for such variation?
Answers were Sorted based on User's Feedback
Answer / sasikumar.r
Not necessaty to investigate.....
As per USP Acceptance Criteria for
S1 is 6 Each unit is not less than Q + 5%.
If individual values passes the Q+5% means, that batch passes the dissolution..
Is This Answer Correct ? | 3 Yes | 0 No |
Answer / b.kishan reddy
Dear @Shasikumr %RSD Should be match for the 6 Units. Generally it is 5%.
Is This Answer Correct ? | 0 Yes | 0 No |
CAN WE DETERMINE THE PEAK PURITY IN GAS CHROMATOGRAPHY ANALYSIS?
why you are using benzoic acid for water content determination in TEA
when we talk about change in entropy we consider total entropy means of surround +entropy of system but when we talk about change in Gibss free energy we consider entropy of system.explain with reason.
What is difference between the working standard and reference standard?
why we use pyridine to determine moisture content of acetonel
4. Describe the operation of the Craig apparatus. Chapter.3 Equilibrium Processes in Separations
what is the origin to prepare standard operating procedure
perchloric acid&glacal acetic acid both are acids but reaction is complete in volumetric titrations.how?
Chromatographic Purity is a Qualitative analysis
What is the definition of RRF
Why we are injecting low load standard conc. while analysing Related Substances by HPLC?
Calculate the water content in Di Sodium Tartrate (DST) based on molecular weight?