System Suitability HPLC [August 17, 2004]
Posted: Sun Aug 29, 2004 7:00 pm
By Anon on Tuesday, August 17, 2004 - 11:11 am:
I would like to solicit ideas re the assignment of appropriate suitability tests and acceptance criteria for an extended LC gradient. The method is 60 min including, wash off. I have been using < 2% difference of duplicate injections for RT of the products and peak area of the products. The process is time consuming. Is it plausible to reduce the gradient time, resolve the products earlier and complete the suitability to 1/2 the time? Alternatively, can suitability be performed on a weekly basis?
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By Bharat on Friday, August 20, 2004 - 12:18 am:
Yes it is possible change the gradient. But system suitablity parameter is prime requirement of regulatory authorities.
I would like to solicit ideas re the assignment of appropriate suitability tests and acceptance criteria for an extended LC gradient. The method is 60 min including, wash off. I have been using < 2% difference of duplicate injections for RT of the products and peak area of the products. The process is time consuming. Is it plausible to reduce the gradient time, resolve the products earlier and complete the suitability to 1/2 the time? Alternatively, can suitability be performed on a weekly basis?
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By Bharat on Friday, August 20, 2004 - 12:18 am:
Yes it is possible change the gradient. But system suitablity parameter is prime requirement of regulatory authorities.