Use of recovery factor in nitrosamine analysis in drug product

Confirmatory Testing & Analytical Challenges
1

Hello Everyone,

I developed a nitrosamine method for a drug product. The recovery is 75%. This recovery is acceptable according to USP 1469. However, I have a question about this.

Should I use a recovery factor? I haven’t seen any information in any guides regarding the use of a recovery factor. Do I have to use it because the recovery is low, or can I report without using it?

Thank you.

2

@Hasan_T Ideally recovery factor should be applied if recovery observed below 80% to get the accurate and true value/results, considering the case if impurity is detected in product or results are observed closer to the limit.

3

Thank you for your quick response.

Is this covered in any guides? I’d like to base this topic on a guide.