N-Nitroso 5,6-Dihydro Tofacitinib는 5,6-dihydro tofacitinib 골격의 피페리딘 질소가 N-니트로소화된 니트로사민 관련 불순물이다. 분자식 C16H21N7O2, 분자량 343.38 g/mol로, 공정 유래 또는 분해 유래의 미량 잠재적 유전독성 오염물로 해석된다. 니트로사민은 발암성 우려로 인해 ICH M7 및 관련 위해 기반 규제 체계의 적용을 받는다. 극미량 정량에는 일반적으로 고선택성 LC-MS/MS가 필요하며, 고분해능 질량분석과 직교 크로마토그래피 확인이 종종 병행된다. UV 검출만으로는 복잡한 매트릭스에서 충분한 특이성과 감도를 확보하기 어렵다.
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