I am looking for the procedure of sample preparation for the forced degradation study, what will be the molar concentration of Hcl,NaoH, H2O2 and lux and UV light for the photo stability. How the sample will be prepare, what will be the temperature for the sample ?
There is no requirement for an FD, except Brazil's ANVISA (and it is only a 'thou shalt' document). However, it is a 'really' good idea as it is the 1st step in understanding your API and developing a 'stability indicating' method. Usually, it is the exposure of 100 mg of a active lab mix and placebo (use a glass petri dish used in micro) for 5 days to 0.05 N HCl, 0.05 N NaOH, heat (25C), light (1000 lux), hydrogen peroxide solution for oxidation. Determine the % decrease of the API by chromatography (GC or HPLC, neutralize the sample 1st) each day and note the RRT of other peaks (noting in particular peaks not found in the placebo). Conclude, whether your API is susceptable to commercial exposure to acid, base, heat, light, oxidation and propose how to mitigate the % decrease in API label claim. Do not calculate the mass balance of the 'related substances'!
Thank you...
But I am still having question? During forced degradation Sample should be prepare in 0.1 N HCl ,0.1N NaoH and 3% H2O2 then kept at 60°c or sample is dissolved in certain ml then make the volume up to the mark .
Typically a sample is neutralized (use a pH meter), then diluted to volume with warer, mixed, and injected.
If you use 100 mg API and a volume of 100 mL, then the concentration of the API should be 1 mg/mL. However, be sure you run a sample of 100 mg of API diluted to 100 mL.
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