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 albokrinov

link 4.12.2009 19:37 
Subject: area response pharma.
9) Stability
9.1 Short term stock solution:
The percent of mean ratio of the area response was 104.6%, which was within the acceptance criteria of 90-110%.
9.2 Freeze thaw:
The percentage of change for low and high quality control samples were -5.2% and -1.9%, respectively, after three cycles, which was within the acceptance criteria of ±15%.
9.3 Long term stock solution:
The ratio of means of area responses for the stock solution of anastrozole was 100.9%, which was within the acceptance range of 90%-110%.
The ratio of means of area responses for the stock solution of carbamazepine was 100.1%, which was within the acceptance criteria of 90%-110%.

 OlgaAvdeeva

link 5.12.2009 17:44 
ratio of means of area responses

Под "area response" здесь надо понимать "площадь пика на хроматограмме". Авторы пишут "ratio", так как речь идет не об абсолютном значении площади пика, а о соотношении этой величины с площадью пика стандарта, выраженном в %.
Среднее значение найденных соотношений здесь и приведено.

По сути дела это среднее содержание аналита в %, рассчитанное, исходя из площадей пиков на хроматограммах.

 albokrinov

link 6.12.2009 8:30 
OlgaAvdeeva, большое спсибо

 

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