In quality control Laboratory, During working standard preparation and working standard potency declaration against pharmacopeial CRS, which acceptance criteria should I set? For setting up acceptance criteria should which reference should i follow?
For qualification of working standard, you have to compare its analytical profile with pharmacopoeial CRS. For assay determination, you will have to use pharmacopoeial CRS as a standard, and using its declared potency/purity you will have to calculate the potency /purity of your working standard.
For quantitative determination (like assay, dissolution, content uniformity tests etc.) you can use your working standard only if its potency/purity is within the limits of the pharmacopoeial monograph of that API. If it is less than pharmacopeial limits then you can use that working standard only for qualitative tests such as an identification by FTIR or UV Spectrophotometric methods.
However generally working standards of highest potency/purity and minimum impurity levels should be used for quantitative tests such as assay, dissolution, content uniformity or impurities / Related substances, etc.
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