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White Paper

Addressing the presence of mutagenic Azido impurities in Sartan APIs

Reaction of Halogen substituted biphenyl compound with sodium azide

In continuation to our efforts to understand the Azido impurities, we are evaluating the possibility of formation of two additional Azido impurities - Chloro methyl azido impurity and 4-Chloro azido methyl tetrazole impurity in Losartan potassium. Based on detailed synthetic landscape, it is found that these impurities are not potentially formed in our manufacturing process. The detailed assessment report for the same would be available in the coming few weeks.

Dr. Reddy’s has continued to manufacture and deliver Sartan APIs in accordance with global regulations as a result of the processes and the analytical methods developed by our experts to avoid the presence of Nitrosamine and Azido impurities. We stay committed to ensure that we continue to provide high quality APIs to our partners.

I will be happy to connect with you for any queries or further details on our assessment on Azido impurities in Sartan APIs. You can also log onto XCEED, our customer engagement platform, to raise any sample or technical queries on the topic.

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No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

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