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Chemical Name: Ethyl 3-(3-(2-((4-cyanophenyl)(nitroso)amino)acetamido)-4-(methylamino)-N-(pyridin-2-yl)benzamido)propanoate
Shipping Temperature: Ambient
HSN Code: 38229010
Country of Origin: India
Smiles: O=C(OCC)CCN(C1=NC=CC=C1)C(C2=CC=C(NC)C(NC(CN(C3=CC=C(C#N)C=C3)N=O)=O)=C2)=O
Novel method for separation and quantification of potential impurities by RP-HPLC from KSM stage to API stage of dabigatran mesylateBy Jhansi, T. Naga; Nagaraju, R.; Kumar, D. Jaya Deep; Rao, G. NageswaraFrom International Journal of Pharmaceutical Sciences and Research (2021), 12(3), 1762-1779 Development and Validation of RP-UPLC Method for the Determination of Process and Degradant Impurities Present in Dabigatran Etexilate Mesylate Capsules Using High Strength Silica-T3 Sorbent ColumnBy Mantena, Bhaskara P. V.; Rao, Sumathi V.; Suryakala, D.; Ramakrishna, K.; Srikanth Reddy, R.From Analytical Chemistry Letters (2016), 6(5), 595-611 Determination of dabigatran etexilate mesylate by HPLCBy Jia, Ling-xiao; Tang, Lei; Zhang, Shu-ting; Song, Rui-zhi; Gao, Zhan-wenFrom Shipin Yu Yaopin (2015), 17(3), 195-197
Dabigatran Nitroso Impurity 25 is chemically Ethyl 3-(3-(2-((4-cyanophenyl)(nitroso)amino)acetamido)-4-(methylamino)-N-(pyridin-2-yl)benzamido)propanoate. Dabigatran Nitroso Impurity 25 is supplied with detailed characterization data compliant with regulatory guideline. Dabigatran Nitroso Impurity 25 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Dabigatran.
The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.
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