By Rita Rocha on Sunday, September 12, 1999 - 07:16 am:
I'm new to HPLC method development for purity and content uniformity of formulations.
My question is in regards to Forced degration studies of the drug component during validation of the method. Should the degradation of the component be controlled so as to allow only 10-30 % of the component label claim to be degraded?
All responses are appreciated.
Also can you refer me to some current literature on the subject?
Thanks in advance.
By Rajini Pothapu on Tuesday, September 14, 1999 - 10:36 am:
It is preferable to have the degradation within 10-30%. Trying to further degrade the active component with stronger conditions may degrade the degradation products. This will create too many unnecessary peaks.
By Wilhelm on Monday, September 20, 1999 - 05:51 pm:
Yes, as per FDA and ICH guidelines. However, if the active/drug is stable even under severe stressed condition(s)e.g. reflux in 0.1N NaOH, you have no choice but leave it as so. The rationale is to generate the degradants in order to demonstrate your method being stability indicating. On the other hand, overstress could cause additional problems such as mass balance.
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