Olodaterol Nitroso Impurity NEW

Olodaterol Nitroso Impurity;C28H31N3O6 

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

Product Information

• Product Code：O027049

• English Name：Olodaterol Nitroso Impurity 49

• English Alias：(R)-N-(2-(6-(benzyloxy)-3-oxo-3,4-dihydro-2H-benzo[b][1,4]oxazin-8-yl)-2-hydroxyethyl)-N-(1-(4-methoxyphenyl)-2-methylpropan-2-yl)nitrous amide

• CAS No.：Not provided (to be supplemented)

• Molecular Formula：C₂₈H₃₁N₃O₆

• Molecular Weight：505.56

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Olodaterol impurity analysis.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in acetonitrile-methanol within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 49 in Olodaterol API and formulations, meeting ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization：Monitors impurity formation during synthesis, reducing generation by >40% by adjusting nitrosation temperature (e.g., 0-5℃) and reaction time.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

Background Description

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution separates impurities within 10 min, with LOD of 0.005 ng/mL.

• Formation Mechanism：Formed by nitrosation of amino-containing intermediates with sodium nitrite under acidic conditions (e.g., acetic acid system); optimizing acid concentration and reaction time inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 185.7 μM against BEAS-2B cells (Olodaterol IC₅₀=9.2 μM). Although less toxic than the main drug, content control is required, and long-term stability testing is in progress.

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

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!