What is use of ROI and Heavy metal Test… What is the purpose we conducting those tests?
Use of Residue on ignition and Heavy metals tests indicate presence of unwanted impurities in organic compounds. Like, metallic impurities in the form of their oxides after ignition of organic compounds and detection of metallic impurities in Heavy metals test. These , when present beyond the specified limits in the pharmacopoeial specifications can be harmful to human body upon consumption. Therefore, generally such impurities are controlled in the pharmaceutical raw materials which are used for manufacturing of drug products.
ROI and heavy metals tests are performed to ensure the inorganic impurities of the substance
If spec limt 0.5 w\w , we got 0.55% …Then we treat it’s a failed…
But, some of the recent procedures … ignition and Charing required until two consecutive results!! (0.05 g different be two results).
In this case we reignite the every sample, then it will be pass!!
Wt is the use of this new method of two consecutive results will be must be match??
Let me know the difference between old ROI(single time method) and Present ROI(until two consecutive results)??