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¡ï koalaone: ½ð±Ò+1 2012-11-13 07:54:07
My experience as your reference:
1. ÆøÏà²â²ÐÁôÈܼÁµÄ»ØÊÕÂÊ: 80%-120%.
2. ÔÁϲÐÁôÈܼÁµÄ·½·¨Ñ§ÑéÖ¤£¬µ«²âµÃµÄ»ØÊÕÂʱȽϸß: since you are working on ÔÁϲÐÁôÈܼÁ, you cannot add your reference standard to placebo to measure your recovery. You only can use ÔÁÏ + 80%, 100%, 120% working standard solution (100% working standard solution is ICH limit level) to calculate recovery%. To troubleshooting »ØÊÕÂʱȽϸß
1) When you measure your sample(ÔÁÏ), you may measure your sample n=3 or 5 to get mean value.
2) Prepare sample in a fast or correct way (ÎÒ100mg¶¨Èݵ½1ml, this is not normal way to do, the volume is too low that will be difficult to manage sample evaporation) to avoid sample evaporation.
3) Sample + matrix interaction may cause this issue too. You can try different solvent (matrix) to dissolve your sample.
4) If still cannot get right recovery%, you may try internal standard or external standard method. |
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