NDMA Formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product.

Golob, Nejc; Peterlin, Simona; Grahek, Rok; Roskar, Robert

Golob, Nejc; Peterlin, Simona; Grahek, Rok; Roskar, Robert.

Affiliation

Golob N; Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Ljubljana, Slovenia; University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia.
Peterlin S; Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Ljubljana, Slovenia.
Grahek R; Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Ljubljana, Slovenia.
Roskar R; University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia. Electronic address: robert.roskar@ffa.uni-lj.si.

J Pharm Sci ; 112(5): 1277-1286, 2023 05.

Article in En | MEDLINE | ID: mdl-36925105

Subject(s)

Dimethylnitrosamine; Nitrosamines; Humans; Dimethylnitrosamine/metabolism; Nitrites; Afatinib; Povidone; Hydrogen-Ion Concentration

Key words

Afatinib drug product; Crospovidone; Dimethylamine (DMA); Drug substance degradation; Excipient; N-Nitrosodimethylamine (NDMA); Nitrite; Stability study

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Dimethylnitrosamine / Nitrosamines Type of study: Prognostic_studies Limits: Humans Language: En Journal: J Pharm Sci Year: 2023 Type: Article Affiliation country: Slovenia

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