In addition, the MHLW recently notified that NDMA impurity in valsartan drug substances should not exceed 0.599 ppm 2. in Japan announced a voluntary product recall of valsartan-containing drugs, because they found that there could be a risk of contamination of NDMA in the API purchased from Zhejiang Huahai Pharmaceutical 1. Simultaneously, ASKA Pharmaceutical Co., Ltd. On 6 th July 2018, the Ministry of Health, Labour and Welfare (MHLW) in Japan released that N-nitrosodimethylamine (NDMA) was detected as an impurity in valsartan-containing drugs whose API was supplied by Zhejiang Huahai Pharmaceutical in China. Valsartan, an angiotensin II receptor antagonist, is mainly used for the treatment of hypertension and congestive heart failure. Valsartan-containing drugs contain the active pharmaceutical ingredient (API) valsartan. Our method would be useful for the rapid screening and quantification of NDMA impurity in valsartan drug substances and products. ![]() Moreover, six samples (valsartan drug substances and tablet formulations), which had a possibility for NDMA contamination, were analyzed none of the samples contained NDMA at detectable levels. When the recalled valsartan samples were subjected to this method, the observed NDMA contents were in agreement with the reported values, indicating that our method achieved sufficient linearity, accuracy, and precision to detect NDMA in valsartan drug substances and products. The limits of detection and quantification were 0.0085 μg/mL and 0.0285 μg/mL, respectively. ![]() Good linearity with a correlation coefficient (R 2) > 0.999 was achieved over the concentration range of 0.011–7.4 µg/mL. In this study, an HPLC method was developed for the quantitative detection of NDMA simultaneously eluted with valsartan. ![]() In July 2018, certain valsartan-containing drugs were voluntary recalled in Japan owing to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen.
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