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Document is written policies, process description,
procedures nd blank forms.
Record is an information captured on worksheets, forms nd
charts.
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process of Diclofenac sodium,IP.
which batch require to use for analytical method validation?
Why we used in n-butyl acetate water content terminology while in ethyl acetate we used moisture content terminology?
What are the primary considerations in extractables and Leachables ?
What is similarity factor?
how we can identify the impurity is coming below loq at transfering site?
How we performed the force degradation for drug substance, is any specific guideline is available for each parameter(Acidic, basic, oxidation,heat)? what conditions you mentained for above parameters.
Identify problem faced when mass spectroscopy is used with HPLC system ?
if you have given one product then how you determine the impurity in that?
For standardization of volumetric solutions, acceptance limit for concentration is considered as 10% of nominal concentration and %RSD as NMT 0.2% (for appropriate no. of replicates). But , if %RSD has not met, what should be further action?
Why sometime potassium ortho phosphate mix with acetone use for sample preparation for hplc
Principle of single pan analytical balance
Why sodium hydroxide used for maintain pH of phosphate buffer
if peak get problamatic then what require to do?
How do we fix the sample concentaryion in hplc method development. What is the basis?
