Regulatory Open Forum

Dear Member,

              We would like to perform the FTIR method validation for the quantitative determination of Mebendazole polymorph C in the finished product. For the same  wave number of 640cm^-1 and 660cm^-1 were selected for the quantitative analysis based on the vendor method and Chinese pharmacopoeia. 

1. Is it acceptable if we select ratio of the absorbance at 640cm^-1 and 660cm^-1 (instead of the individual absorbance) are taken for determination of the concentration of polymorph A in the samples.
2. Is the linearity of the sample will be achieved. with the solid sample at different concentration.
3. Is there any other justification for the selection of wave number of 640cm^-1 and 660cm^-1 for mebendazole polymorph A & C
4. Is there any guidance to perform the FTIR method validation for quantitative analysis.

Thanks in advance for your valuable comments.

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MANOJ PANIGRAHI

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