식품의약품안전처에서 1일 섭취허용량을 설정한 니트로사민류 불순물 목록 (9차, 기준일 2025-02-18)이 게재되었습니다.
< 변경 이력표 >
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순번
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기준일
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변경사항
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1차
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2023-12-13
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최초 게재
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2차
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2024-01-18
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신규 6종 추가
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3차
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2024-03-20
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신규 21종 추가, 변경 1종(N-nitroso-ambroxol)
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4차
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2024-06-21
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변경 2종(N-nitroso-varenicline 등)
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5차
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2024-10-25
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변경 1종(NTTP)
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6차
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2024-11-06
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변경 1종(NNORT)
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7차
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2024-12-04
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신규 12종 추가, 변경 3종, 명칭 변경 2종
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8차
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2025-01-09
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신규 2종 추가, 변경 1종(MeNP)
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9차
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2025-02-18
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신규 8종 추가, 변경 2종(N-nitroso-sertraline 등)
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< 신규 8종 >
1. N-nitroso-2,4-thiazole amine / N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide (NNTA)
- 리토나비르(Ritonavir) 관련, 검토중, 추후 확정 예정
2. N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide
- 미라베그론(Mirabegron) 관련, 400 ng/일
3. N-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide
- 미라베그론(Mirabegron) 관련, 400 ng/일
4. 3-(dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoate (3DPN)
- 벤지다민(Benzydamine) 관련, 400 ng/일
5. N-nitroso-buspirone Impurity 1 / 2-(4-nitrosopiperazine-1-yl)-pyrimidine
- 부스피론(Buspirone) 관련, 400 ng/일
6. N-nitroso-silodosin
- 실로도신(Silodosin) 관련, 1,500 ng/일
7. N-nitroso-desmethyl-edoxaban
- 에독사반(Edoxaban) 관련, 100 ng/일
8. N-nitroso-epinephrine
- 에피네프린(Epinephrine) 관련, 100 ng/일
< 변경 2종 >
1. N-nitroso-N-methylaniline (NMPA)
- (기존) 검토중, 추후 확정 예정 → (변경) 100 ng/일
2. N-nitroso-sertraline
- 설트랄린(Sertraline) 관련, (기존) 검토중, 추후 확정 예정 → (변경) 100 ng/일
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식약처 설정 니트로사민류 불순물 1일 섭취허용량
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기준일 : 2025.2.18.
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연번
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불순물 명칭
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발생 성분
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CPCA분류
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섭취허용량
(ng/일) |
비고
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공개일자
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1
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N-nitrosodi-methylamine, NDMA
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-
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-
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96
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-
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2018-08-06
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2
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N-nitrosodi-ethylamine, NDEA
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-
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-
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26.5
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-
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2018-11-20
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3
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N-nitroso-di-n-butylamine, NDBA
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-
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-
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26.5
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SAR/read-across,
참조물질 NDEA |
2021-11-09
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4
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N-nitrosodipropylamine, NDPA
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-
|
-
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26.5
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SAR/read-across,
참조물질 NDEA |
2021-11-18
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5
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N-nitrosomorpholine, NMOR
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-
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-
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127
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-
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2022-02-17
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6
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N-nitroso-piperidine, NPIP
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-
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-
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1,300
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-
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2023-12-13
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7
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N-nitroso-pyrrolidine, NPYR
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-
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-
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1,700
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-
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2023-12-13
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8
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N-nitroso-diisopropylamine (NDIPA)
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-
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5
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1,500
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-
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2024-12-04
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9
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N-nitroso-ethylisopropylamine (NEIPA)
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-
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3
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400
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-
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2024-12-04
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10
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N-nitroso-N-methyl-4-aminobutyric acid (NMBA)
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-
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4
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1,500
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-
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2024-12-04
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11
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1-methyl-4-nitrosopiperazine (MeNP)
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-
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3
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400
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-
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2025-01-09
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12
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N-nitroso-N-methylaniline (NMPA)
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-
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2
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100
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-
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2025-02-18
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13
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2-nitroso-octahydrocyclopenta(c)pyrrole
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글리클라지드(Gliclazide)
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-
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1,700
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SAR/read-across, 참조물질 NPYR3)
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2023-12-13
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14
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N-nitroso-nebivolol, NNEB
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네비보롤(Nebivolol)
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4
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1,500
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-
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2023-12-13
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15
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N-nitroso-nortriptyline (NNORT)
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노르트립틸린(Nortriptyline)
아미트립틸린(Amitriptyline) |
1
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26.5
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-
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2024-11-06
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16
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N-nitroso-desmethyl-nintedanib
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닌테다닙(Nintedanib)
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3
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400
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-
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2024-03-20
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17
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N-nitroso-dabigatran etexilate
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다비가트란(Dabigatran)
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-
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1,500
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AMES 음성
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2024-06-21
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18
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N-nitroso-desloratadine
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데스로라타딘(Desloratadine)
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3
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400
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-
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2023-12-13
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19
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N-nitroso-N-desmethyl-desvenlafaxine
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데스벤라팍신(Desvenlafaxine)
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1
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26.5
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-
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2023-12-13
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20
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N-nitroso-N-desmethyl-dextromethorphan
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덱스트로메토르판(Dextromethorphan)
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4
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1,500
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-
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2024-12-04
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21
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N-nitroso-dorzolamide
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도르졸라미드(Dorzolamide)
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2
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100
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-
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2023-12-13
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22
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N-nitroso-nordoxepin
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독세핀(Doxepin)
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1
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26.5
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-
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2023-12-13
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23
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N-desmethyl-N-nitroso-doxycycline
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독시사이클린(Doxycycline)
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3
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400
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-
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2023-12-13
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24
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N-nitroso-N-methyl-2-[1-phenyl-1-(2-pyridinyl)methoxy]ethanamine
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독실아민(Doxylamine)
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1
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26.5
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-
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2023-12-13
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25
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N-nitroso-duloxetine
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둘록세틴(Duloxetine)
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-
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100
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SAR/read-across, 참조물질 NNK1)
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2023-12-13
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26
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N-nitroso-N-desmethyl-diphenhydramine
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디멘히드리네이트(Dimenhydrinate)
디펜히드라민(Diphenhydramine) |
1
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26.5
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2025-01-09
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27
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N-nitroso-diclofenac
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디클로페낙(Diclofenac)
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5
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1,500
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-
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2023-12-13
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28
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N-nitroso-ranolazine impurity 1
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라놀라진(Ranolazine)
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3
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400
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-
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2024-03-20
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29
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N-nitroso-ramipril
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라미프릴(Ramipril)
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5
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1,500
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-
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2023-12-13
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30
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N-nitroso-labetalol
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라베타롤(Labetalol)
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4
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1,500
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-
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2023-12-13
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31
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N-nitroso-rasagiline
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라사길린(Rasagiline)
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2
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100
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-
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2023-12-13
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32
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N-nitroso-levofloxacin
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레보플록사신(Levofloxacin)
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4
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1,500
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-
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2023-12-13
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33
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N-nitroso-2,6-pipecoloxilidide
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로피바카인(Ropivacaine)
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4
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1,500
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-
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2023-12-13
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34
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N-nitroso-folinic acid: N-[4-[[(2-amino-5-formyl-3,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]nitrosoamino]benzoyl]-L-glutamic acid
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류코보린(Leucovorin)
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4
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1,500
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-
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2023-12-13
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35
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N-nitroso-desethyllidocaine
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리도카인(Lidocaine)
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2
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100
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-
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2024-03-20
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36
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N-Nitroso-rivaroxaban amide /
(S)-5-chloro-N-(2-hydroxy-3-(nitroso (4-(3-oxomorpholino)phenyl)amino) propyl)thiophene-2-carboxamide |
리바록사반(Rivaroxaban)
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4
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1,500
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-
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2024-03-20
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37
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N-Nitroso-rivaroxaban open-ring acid /
(S)-2-(2-((4-(5-((5-chlorothiophene-2-carboxa(nitrosmido)methyl)-2-oxooxazolidin-3-yl)phenyl)o)amino)ethoxy) acetic acid |
리바록사반(Rivaroxaban)
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4
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1,500
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-
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2024-03-20
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38
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Rivaroxaban Nitroso Impurity 1 /
N-(2-hydroxyethyl)-N-phenyl-nitrous amide |
리바록사반(Rivaroxaban)
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4
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1,500
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-
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2024-12-04
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39
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Rivaroxaban Nitroso Impurity 2 /
N-(3-(1,3-dioxoisoindolin-2-yl)-2-hydroxypropyl)-N-(4-(3-oxomorpholino) phenyl)nitrous amide |
리바록사반(Rivaroxaban)
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4
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1,500
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-
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2024-12-04
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40
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Rivaroxaban Nitroso Impurity 5 /
N-(3-Chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide |
리바록사반(Rivaroxaban)
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4
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1,500
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-
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2024-12-04
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41
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N-nitroso-N-desmethyl rivastigmine
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리바스티그민(Rivastigmine)
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2
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100
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-
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2023-12-13
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42
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N-nitroso-ribociclib impurity 1
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리보시클립(Ribociclib)
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3
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400
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-
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2024-03-20
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43
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N-nitroso-lisinopril
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리시노프릴(Linsinopril)
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5
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1,500
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-
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2023-12-13
|
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44
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N-nitroso-2,4-thiazole amine /
N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide (NNTA) |
리토나비르(Ritonavir)
|
-
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검토중,
추후 확정 예정 |
-
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-
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45
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N-nitroso-meropenem
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메로페넴(Meropenem)
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4
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1,500
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-
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2023-12-13
|
|
46
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N-nitroso-metoprolol
|
메토프롤롤(Metoprolol)
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4
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1,500
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-
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2023-12-13
|
|
47
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N-nitroso-methylphenidate, NMPH
|
메틸페니데이트(Methylphenidate)
|
-
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1,300
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SAR/read-across, 참조물질 NPIP2)
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2023-12-13
|
|
48
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N-nitroso-moxifloxacin
|
목시플록사신(Moxifloxacin)
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4
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1,500
|
-
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2023-12-13
|
|
49
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N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide
|
미라베그론(Mirabegron)
|
3
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400
|
-
|
2025-02-18
|
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50
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N-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide
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미라베그론(Mirabegron)
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3
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400
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-
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2025-02-18
|
|
51
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N-nitroso-mirabegron
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미라베그론(Mirabegron)
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3
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400
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-
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2023-12-13
|
|
52
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N-nitroso-mirtazapine
|
미르타자핀(Mirtazapine)
|
3
|
400
|
-
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2024-03-20
|
|
53
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N-nitroso-varenicline, NNV
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바레니클린(Varenicline)
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3
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400
|
-
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2024-06-21
|
|
54
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N-nitroso-N-ethyl-valacyclovir
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발라시클로비르(Valacyclovir)
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3
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400
|
-
|
2023-12-13
|
|
55
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N-nitroso-N-methyl-valacyclovir
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발라시클로비르(Valacyclovir)
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3
|
400
|
-
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2023-12-13
|
|
56
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N-nitroso-valsartan cyano-desvalerylmethylester
|
발사르탄(Valsartan)
|
2
|
100
|
-
|
2024-12-04
|
|
57
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N-nitroso-betahistine
|
베타히스틴(Betahisitne)
|
1
|
26.5
|
-
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2023-12-13
|
|
58
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N-nitroso-betaxolol
|
베탁솔롤(Betaxolol)
|
4
|
1,500
|
-
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2024-03-20
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|
59
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3-(dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoate (3DPN)
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벤지다민(Benzydamine)
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3
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400
|
-
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2025-02-18
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60
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N-nitroso-vortioxetine
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보티옥세틴(Vortioxetine)
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3
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400
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-
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2023-12-13
|
|
61
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N-nitroso-buspirone Impurity 1 /
2-(4-nitrosopiperazine-1-yl)-pyrimidine |
부스피론(Buspirone)
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3
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400
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-
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2025-02-18
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|
62
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N-nitroso-bupropion
|
부프로피온(Bupropion)
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5
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1,500
|
-
|
2023-12-13
|
|
63
|
N-nitroso-bisoprolol, NBP
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비소프롤롤(Bisoprolol)
|
4
|
1,500
|
-
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2023-12-13
|
|
64
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N-nitroso vildagliptin amide impurity
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빌다글립틴(Vildagliptin)
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5
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1,500
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-
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2024-12-04
|
|
65
|
N-nitroso-vildagliptin
|
빌다글립틴(Vildagliptin)
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5
|
1,500
|
-
|
2023-12-13
|
|
66
|
N-nitroso-salbutamol
|
살부타몰(Salbutamol)
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5
|
1,500
|
-
|
2023-12-13
|
|
67
|
N-nitroso-sertraline
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설트랄린(Sertraline)
|
2
|
100
|
-
|
2025-02-18
|
|
68
|
N-nitroso-celiprolol
|
셀리프롤롤(Celiprolol)
|
5
|
1,500
|
-
|
2024-03-20
|
|
69
|
N-nitroso-sotalol
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소타롤(Sotalol)
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4
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1,500
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-
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2023-12-13
|
|
70
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3-[2-(N-nitroso-N-methyl)amino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide
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수마프립탄(Sumatriptan)
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1
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26.5
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-
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2023-12-13
|
|
71
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N-nitroso-pseudoephedrine
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슈도에페드린(Pseudoephedrine)
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4
|
1,500
|
-
|
2023-12-13
|
|
72
|
N-nitroso-cinacalcet
|
시나칼세트(Cinacalcet)
|
3
|
400
|
-
|
2024-01-18
|
|
73
|
2,2,5-trimethyl-3-nitroso-1,3-oxazolidine
|
시아노코발라민(Cyanocobalamine)
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4
|
1,500
|
-
|
2024-12-04
|
|
74
|
7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3- a]pyrazine, NTTP
|
시타글립틴(Sitagliptin)
|
2
|
100
|
-
|
2024-10-25
|
|
75
|
N-nitroso-desmethyl citalopram
|
시탈로프람(Citalopram)
|
1
|
26.5
|
-
|
2023-12-13
|
|
76
|
N-nitroso-ciprofloxacin
|
시프로플록사신(Ciprofloxacin)
|
4
|
1,500
|
-
|
2024-01-18
|
|
77
|
1-diphenylmethyl-4-nitrosopiperazine
|
신나리진(cinnarizine)
|
3
|
400
|
|
2025-01-09
|
|
78
|
N-nitroso-desmethyl-sildenafil
|
실데나필(Sildenafil)
|
3
|
400
|
-
|
2024-03-20
|
|
79
|
N-nitroso-cilazapril
|
실라자프릴(Cilazapril)
|
5
|
1,500
|
-
|
2023-12-13
|
|
80
|
N-nitroso-silodosin
|
실로도신(Silodosin)
|
4
|
1,500
|
-
|
2025-02-18
|
|
81
|
1-(2,3-dichlorophenyl)-4-nitrosopiperazine
|
아리피프라졸(Aripiprazole)
|
3
|
400
|
-
|
2024-03-20
|
|
82
|
N-nitroso-desmethyl-azelastine
|
아젤라스틴(Azelastine)
|
2
|
100
|
-
|
2024-03-20
|
|
83
|
N-nitroso-azaerythromycin
|
아지스로마이신(Azithromycin)
|
-
|
ICH Q3A/Q3B에 따라 관리
|
비변이원성 불순물
|
2023-12-13
|
|
84
|
N-nitroso-desmethylazithromycin
|
아지스로마이신(Azithromycin)
|
-
|
ICH Q3A/Q3B에 따라 관리
|
비변이원성 불순물
|
2023-12-13
|
|
85
|
N-nitroso-atenolol
|
아테놀롤(Atenolol)
|
4
|
1,500
|
-
|
2023-12-13
|
|
86
|
N-nitroso-Atomoxetine
|
아토목세틴(Atomoxetine)
|
-
|
100
|
SAR/read-across, 참조물질 NNK1)
|
2024-03-20
|
|
87
|
N-nitroso-apixaban impurity B
|
아픽사반(Apixaban)
|
4
|
1,500
|
-
|
2024-12-04
|
|
88
|
3-amino-N-nitrosopiperidine
|
알로글립틴(Alogliptin)
|
3
|
400
|
-
|
2024-01-18
|
|
89
|
N-nitroso-ambroxol
|
암브록솔(Ambroxol)
|
-
|
1,500
|
AMES 음성
|
2024-03-20
|
|
90
|
N-nitroso-enalapril
|
에날라프릴(Enalapril)
|
5
|
1,500
|
-
|
2023-12-13
|
|
91
|
N-nitroso-desmethyl-edoxaban
|
에독사반(Edoxaban)
|
2
|
100
|
-
|
2025-02-18
|
|
92
|
N-nitroso-esmolol
|
에스몰롤(Esmolol)
|
4
|
1,500
|
-
|
2024-01-18
|
|
93
|
N-nitroso-epinephrine
|
에피네프린(Epinephrine)
|
2
|
100
|
-
|
2025-02-18
|
|
94
|
N-nitroso-folic acid, NFA
|
엽산/폴산(Folic acid)
|
4
|
1,500
|
-
|
2023-12-13
|
|
95
|
N-nitroso-N-desmethylorphenadrine, NMOA
|
오르페나드린(Orphenadrine)
|
1
|
26.5
|
-
|
2023-12-13
|
|
96
|
N-nitroso-imatinib
|
이매티닙(Imatinib)
|
5
|
1,500
|
-
|
2024-03-20
|
|
97
|
N-nitroso-ethylenediamine-triacetic acid
|
이소소르비드 모노니트레이트
(Isosorbide mononitrate) |
4
|
1,500
|
-
|
2024-03-20
|
|
98
|
N-nitroso-iminodiacetic acid
|
이소소르비드 모노니트레이트
(Isosorbide mononitrate) |
4
|
1,500
|
-
|
2024-03-20
|
|
99
|
Indapamide Impurity A
|
인다파미드(Indapamide)
|
5
|
1,500
|
-
|
2024-03-20
|
|
100
|
N-nitroso-ketamine
|
케타민(Ketamine)
|
5
|
1,500
|
-
|
2023-12-13
|
|
101
|
N-nitroso Quetiapine HEEP Impurity
|
쿠에티아핀(Quetiapine)
|
-
|
1,500
|
AMES 음성
|
2024-03-20
|
|
102
|
N-nitroso-aryl piperazine / N-nitroso-desalkylquetiapine, NDAQ
|
쿠에티아핀(Quetiapine)
|
3
|
400
|
-
|
2023-12-13
|
|
103
|
N-nitroso-N-desmethyl clarithromycin
|
클래리트로마이신(Clarithromycin)
|
4
|
1,500
|
-
|
2023-12-13
|
|
104
|
N-nitroso-cloazpine
|
클로자핀(Cloazpine)
|
5
|
1,500
|
-
|
2023-12-13
|
|
105
|
N-nitroso-tigecycline
|
타이가사이클린(Tigecycline)
|
5
|
1,500
|
-
|
2023-12-13
|
|
106
|
N-nitroso-tamsulosin
|
탐스로신(Tamsulosin)
|
4
|
1,500
|
-
|
2023-12-13
|
|
107
|
N-nitroso terazosin impurity C /
6, 7-Dimethoxy-2-(1-piperazinyl)-4-quinazolinamine; 2-(1-Piperazinyl)-4-amino-6, 7-dimethoxyquinazoline |
테라조신(Terazosin)
|
3
|
400
|
-
|
2024-12-04
|
|
108
|
N-nitroso terazosin impurity N /
(4-Nitrosopiperazin-1-yl) (tetrahydrofuran-2-yl)methanone |
테라조신(Terazosin)
|
3
|
400
|
-
|
2024-12-04
|
|
109
|
N-nitroso-desmethyl terbinafine
|
테르비나핀(Terbinafine)
|
1
|
26.5
|
-
|
2024-03-20
|
|
110
|
N-nitroso-terbinafine impurity A
|
테르비나핀(Terbinafine)
|
1
|
26.5
|
-
|
2024-03-20
|
|
111
|
N-nitroso-tetracaine
|
테트라카인(Tetracaine)
|
3
|
400
|
-
|
2024-01-18
|
|
112
|
N-nitroso-desmethyl-tramadol
|
트라마돌(Tramadol)
|
1
|
26.5
|
-
|
2024-12-04
|
|
113
|
N-nitroso-desmethyl trimebutine
|
트리메부틴(Trimebutine)
|
5
|
1,500
|
-
|
2023-12-13
|
|
114
|
N-nitroso-trimetazidine, NTMZ
|
트리메타지딘(Trimetazidine)
|
3
|
400
|
-
|
2023-12-13
|
|
115
|
N-nitroso-ticagrelor
|
티카그렐러(Ticagrelor)
|
5
|
1,500
|
-
|
2024-01-18
|
|
116
|
N-nitroso-paroxetine
|
파록세틴(Paroxetine)
|
-
|
1,300
|
SAR/read-across, 참조물질 NPIP2)
|
2023-12-13
|
|
117
|
N-nitroso-phenylephrine
|
페닐레프린(Phenylephrine)
|
2
|
100
|
-
|
2023-12-13
|
|
118
|
N-nitroso-perindopril
|
페린도프릴(Perindopril)
|
5
|
1,500
|
-
|
2023-12-13
|
|
119
|
N-nitroso-felodipine
|
펠로디핀(Felodipine)
|
5
|
1,500
|
-
|
2023-12-13
|
|
120
|
N-nitroso-calcium folinate
|
폴리네이트칼슘
(Calcium folinate/ Calcium levofolinate) |
-
|
ICH Q3A/Q3B에 따라 관리
|
비변이원성 불순물
|
2024-03-20
|
|
121
|
N-nitroso-furosemide
|
푸로세미드(Furosemide)
|
4
|
1,500
|
-
|
2023-12-13
|
|
122
|
N-nitroso-pramipexole
|
프라미펙솔(Pramipexole)
|
3
|
400
|
-
|
2023-12-13
|
|
123
|
N-nitroso-frovatriptan/(3R)-2,3,4,9-tetrahydro-3-(N-methyl(nitroso)amino)-1H-carbazole-6-carboxamide
|
프로바트립탄(Frovatriptan)
|
3
|
400
|
-
|
2023-12-13
|
|
124
|
N-nitroso-propanolol
|
프로프라놀롤(Propanolol)
|
4
|
1,500
|
-
|
2023-12-13
|
|
125
|
N-nitroso-flecainide
|
플레카이니드(Flecainide)
|
4
|
1,500
|
-
|
2023-12-13
|
|
126
|
N-nitroso-fluoxetine
|
플루옥세틴(Fluoxetine)
|
-
|
100
|
SAR/read-across, 참조물질 NNK1)
|
2023-12-13
|
|
127
|
N-nitroso-hydrochlorothiazide
|
히드로클로로티아지드(Hydrochlorothiazide)
|
-
|
ICH Q3A/Q3B에 따라 관리
|
비변이원성 불순물
|
2023-12-13
|
|
|
|
|
|
|
|
|
|
1) NNK : 4-(methylnitrosoamino)-1-(3-pyridinyl)-1-butanone
2) NPIP : N-nitroso-piperidine 3) NPYR : N-nitroso-pyrrolidine |
||||||
(2025-02-18) 식약처 설정 니트로사민류 불순물 1일 섭취허용량 목록 갱신 (9차)
식품의약품안전처에서 1일 섭취허용량을 설정한 니트로사민류 불순물 목록 (9차, 기준일 2025-02-18)이 게...
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