Atorvastatin EP Impurity A는 Atorvastatin Related Compound A 또는 Desfluoro Atorvastatin(free base)로도 불리며, 스타틴 골격에서 합성 중 또는 관련 부반응 경로에서 p-플루오로페닐기의 탈불소화로 생성되는 구조적으로 정의된 공정 유래 불순물이다. CAS 433289-84-0, 분자식 C33H36N2O5, 분자량 540.65 g/mol을 가진다. 비휘발성이고 지용성인 분해 생성물 및 공정 관련 불순물로서, 동정과 정량에는 LC-MS/MS, 고분해능 질량분석, UV 또는 DAD 검출 HPLC의 직교적 분석이 요구되며 필요 시 NMR로 확증한다. 일반적으로 ICH M7 관점의 유전독성 물질로 분류되지는 않으며 불순물 프로파일링의 대상이다.
References
“Atorvastatin (Oral Route) Description and Brand Names – Mayo Clinic.†Mayoclinic.org, 2023, www.mayoclinic.org/drugs-supplements/atorvastatin-oral-route/description/drg-20067003. Accessed 15 Apr. 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s056lbl.pdf ‌
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