The nitrosamine contamination of drugs, part 3: Quantification of 4-Methyl-1-nitrosopiperazine in rifampicin capsules by LC-MS/HRMS.
J Pharm Biomed Anal
; 203: 114205, 2021 Sep 05.
Article
en En
| MEDLINE
| ID: mdl-34130010
ABSTRACT
Upon emergence of nitrosamines in various drugs, e.g in valsartan, metformin and ranitidine, 4-methyl-1-nitrosopiperazine (MeNP) was found in rifampicin in August 2020. Rifampicin is used, amongst others, for post-exposure prophylaxis of leprosy. The occurrence of MeNP can be explained by the synthesis, because 1-amino-4-methylpiperazine is concomitantly used with the organic oxidizing reagent isoamyl nitrite. According to a method reported by the FDA, the quantification of MeNP in rifampicin capsules was performed by LC-MS/HRMS. A significant contamination with MeNP was found in all samples, ranging from 0.7 to 5.1 ppm and exceeding the acceptable intake limit proposed by the FDA up to 32-fold. However, the severity of a possible leprosy infection outweighs the risks, which are concomitant with the intake of a single dose of rifampicin for post-exposure prophylaxis. Nevertheless, the extent of contamination is alarming, and countermeasures are needed to minimize public health risks. The presence of nitrosamines in rifampicin illustrates the need for better strategies in impurity profiling and compendial testing once again.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
3_ND
Problema de salud:
3_leprosy
/
3_neglected_diseases
Asunto principal:
Rifampin
/
Nitrosaminas
Tipo de estudio:
Risk_factors_studies
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2021
Tipo del documento:
Article
País de afiliación:
Alemania