Chromatography Forum

Any official guidance for Accuracy range for spiking for trace level analysis (say 5 to 25ppm) of an impurity in a method we want to validate for use in US ?

Australian Pharma lists 75-125%. For drug actives we use FDA ORA of 95.0 - 105.0%, but are searching for written guidance (such as ICH) for low level assays.

Also, we'd like guidance as to what %RSD should be for system suitability for this. We've seen somewhat similar in USP for a 500 ppm max limit of an impurity where USP specified RSD of 5%. Thanks.

Any official guidance for Accuracy range for spiking for trace level analysis (say 5 to 25ppm) of an impurity in a method we want to validate for use in US ?

Australian Pharma lists 75-125%. For drug actives we use FDA ORA of 95.0 - 105.0%, but are searching for written guidance (such as ICH) for low level assays.

Also, we'd like guidance as to what %RSD should be for system suitability for this. We've seen somewhat similar in USP for a 500 ppm max limit of an impurity where USP specified RSD of 5%. Thanks.

U can refer to the USP general chapter 233 and 233 heavy metals. I think accuracy range of 75-125% and RSD of 15% are acceptable.