how much we need to spike the compound and How we conclude it
In a validation, we generally use to spike the certain amount onto the Diluent or sometimes onto the Placebo. My doubt is how to and how much we need to spike the compound and How we conclude it
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Sir
As per your question, I could understand that you are asking about the spiking amount of Impurity.
In General, for validation, we will spike the Impurity of mentioned specification Level. That means, the amount of concentration of spiking of an Impurity is the Percentage of Specification
Here, I will explain you with example:
Suppose, If you have an Impurity and its specification is NMT 0.2%, here you should calculate the mentioned % with respect to sample concentration
Imagine your given sample concentration is 100ppm. Then the 0.2% percentage is 0.2ppm. Then, you should prepare a stock of Impurity of certain concentration that is above mentioned spec level and the spiked the volume is equivalent to 0.2ppm.
Likewise, the amount of concentration for the spiking can be confirmed.
Above mentioned explanation is applicable for specificity.
Spiking is done on Placebo in Accuracy as we check the Recovery and In Linearity, we go with diluent.