I am planning to develop & Validate RS method for pharmaceutical Cream, Here i mentioned my doubts. please clarify
1.How to fix the conc of impurities for validation (Semisolids how to fix the conc? because as per ICH guidelines Therapeutic daily dose is not possible for Cream)
2. For my molecule, monograph mentioned nearly 14 impurities , shall we do the validation for all impurities or degradation impurities only? In this case how to identify degradation impurity?
3. How to initate Method development & validation for RS? Please send any RS method protocol if cream means fine
For #2, to ID a degradation impurity, would you not do the usual forced degradation experiments: acid, base, heat, light, H2O2, and then run your method and measure retention times and spectra to compare to your impurities?
For knowing the limit of impurities/related compounds, I think you can read the monograph in official Pharmacopeia (as a guidance for your work). It will be nice if you have standard of all impurities to prove the selectivity of the propose method. If it is not available than you can do force degradation studies as recommended by Dr. Bernart above.
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