N-Nitroso Tranexamic Acid
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Well-defined with distinct functional groups: Contains two cyclohexanecarboxylic acid units and nitrosoazanediyl (-N(NO)-) linked by bis(methylene) groups. Unlike tranexamic acid (antifibrinolytic with amino cyclohexanecarboxylic acid), its nitroso polarity, dicarboxyl hydrophilicity, and cyclohexane hydrophobicity create significant differences, enabling precise differentiation via HPLC/ion-exchange chromatography as a specific marker;
High stability and traceability: Rigid cyclohexane structures and stability of carboxyl/C-N bonds ensure stability under dark, low-temperature conditions. As a byproduct from amino nitrosation during storage/degradation of tranexamic acid, it directly reflects amino reactivity and nitrite exposure risk, improving process tracing accuracy;
High detection sensitivity: Conjugation between nitroso and carbon chains shows characteristic UV absorption (230-260nm), combined with m/z 327 [M+H]⁺ enabling ppb-level analysis via LC-MS, compatible with antifibrinolytic nitroso impurity systems.
Pharmaceutical quality control: Used as an impurity reference standard to quantify N-Nitroso Tranexamic Acid in APIs, ensuring compliance with genotoxic impurity limits in pharmaceutical standards;
Stability studies: Monitoring impurity levels under varying conditions (pH, light) to assess nitrosation trends and support safety assurance over shelf life;
Synthesis assessment: Evaluating purity of amino-containing intermediates in tranexamic acid synthesis to reduce nitrosation risk at the source.
Tranexamic Acid is an antifibrinolytic agent with amino cyclohexanecarboxylic acid structure, acting by inhibiting fibrinolysis, containing a primary amine group (-NH₂). Upon exposure to nitrous acid (e.g., from nitrate conversion) during production or storage, this amine may undergo nitrosation to form nitrosoazanediyl (-N(NO)-) linked bimolecular derivatives like N-Nitroso Tranexamic Acid. Due to potential genotoxicity and carcinogenicity, nitrosoamides are strictly regulated, and their residues may affect tranexamic acid safety, making detection and control critical for quality assurance.
Current research focuses on:
Analytical method validation: Developing HPLC assays with C18 columns for separation, achieving 0.1 ppb detection limits;
Nitrosation mechanism: Studying impurity formation kinetics under varying nitrite concentration and pH to clarify primary amine-to-nitroso derivative conversion pathways;
Control strategies: Exploring nitrosation inhibitors (e.g., ascorbic acid) to keep impurity levels below safety limits (<0.001%);
Toxicity evaluation: Conducting in vitro genotoxicity tests (e.g., Ames assay) to assess hazards and support limit setting.
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
China
