Attention! It has been proven that dihydropyridine calcium channel blockers (CCBs) cannot generate the corresponding nitrosamine structural impurities, and this conclusion has been accepted by the FDA.

Recently, a person claiming to be from Glenmark Pharmaceuticals in India stated that the company has confirmed that drugs ending with "-dipine" cannot generate the corresponding nitrosamine structural impurities, and this conclusion has been accepted by the FDA.

Figure 1: Screenshot of 2024

Earlier, in the 11th issue of the QCS Reference Material R & D Center's WeChat推文 in 2024, an article titled "Issue 11, 2024 | Groundbreaking Conclusion! A Guide to Avoiding Pitfalls with N - Nitrosamine Impurities in 'Dipines'" was published. In the article, based on the experiences of multiple self - developed projects, we reached the conclusion that nitrosamine impurities in dipines do not exist. Recently, we learned that a pharmaceutical company in India has submitted a declaration regarding the nitrosamine impurities in its dipine drugs according to this method, and it has been accepted by the FDA.

Recently, in the USP Nitrosamine Forum, a user named "Dileep5571" posted replies in two discussion groups, namely "Discussion on Nitrosamine Nicardipine Impurities" and "N - Nitrosamine Impurities Listed by the FDA and EMA: N - Nitrosoamlodipine and N - Nitrosfelodipine Cannot Be Synthesized". In the replies, the user stated that their company has confirmed that the N - nitroso impurities of dipine drugs cannot be synthesized, and they have submitted a declaration based on this conclusion, which has been accepted by the FDA.

Meanwhile, other users on the forum reported that the so - called dipine N - nitrosamines provided by multiple suppliers from different countries were all proven to be mislabeled products. They were identified as aromatized impurities rather than N - nitrosamine impurities. The user information indicates that the post was from Glenmark Pharmaceuticals Limited. Founded in 1977, it is one of the leading multinational pharmaceutical companies in India.

Figure 2: USP nitrosamine forum discussion screenshot 1

Figure 3: USP nitrosamine forum discussion screenshot 2

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