N-Nitroso Olodaterol;C21H25N3O6
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E-mail: anna@molcoo.com
Product Code：N031165
English Name：N-Nitroso Olodaterol
English Alias：(R)-N-(2-hydroxy-2-(6-hydroxy-3-oxo-3,4-dihydro-2H-benzo[b][1,4]oxazin-8-yl)ethyl)-N-(1-(4-methoxyphenyl)-2-methylpropan-2-yl)nitrous amide
CAS No.：Not provided (to be supplemented)
Molecular Formula：C₂₁H₂₅N₃O₆
Molecular Weight：415.44
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Olodaterol nitroso impurity analysis.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common organic solvents (such as acetonitrile-methanol) within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of N-Nitroso Olodaterol in Olodaterol API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during Olodaterol synthesis, reducing generation by >40% by adjusting nitrosation temperature (e.g., 0-5℃) and pH.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Olodaterol, a long-acting β₂-adrenergic receptor agonist, is used for treating chronic obstructive pulmonary disease (COPD). N-Nitroso Olodaterol, as a nitrosated impurity of Olodaterol, may originate from side reactions between amino groups and nitrous acid during synthesis. Its nitroso, hydroxyl, and benzoxazine groups may affect drug stability, receptor binding, and safety. With stricter requirements from global regulatory agencies for respiratory drug impurities, studying this impurity is crucial for ensuring drug quality.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 8 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by nitrosation of amino groups in Olodaterol with nitrites under acidic conditions (e.g., pH < 4); optimizing reaction pH and nitrite dosage inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 178.3 μM against BEAS-2B cells (Olodaterol IC₅₀=8.6 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.
NOTE！
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
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