Dobutamine Impurity
Product Code：D044043
English Name：Dobutamine Impurity 43
English Alias：N-(3,4-dimethoxyphenethyl)-4-methoxyaniline
CAS No.：1059182-81-8
Molecular Formula：C₁₇H₂₁NO₃
Molecular Weight：287.35
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), and HRMS, suitable for precise analysis of Dobutamine impurities.
Stability Assurance：Stable for 24 months at 2-8℃ under light-protected, sealed storage; degradation rate <0.3% in methanol solution within 1 month.
Quality Control Testing：Used for HPLC and LC-MS detection of Impurity 43 in Dobutamine API and formulations, controlling impurity content to meet ICH Q3A standards (≤0.1%).
Process Optimization Research：Monitors impurity formation during Dobutamine synthesis, reducing generation by >50% by adjusting condensation temperature (e.g., 60-70℃) and catalyst dosage (e.g., triethylamine).
Method Validation：Serves as a standard for developing impurity detection methods, verifying HPLC resolution (≥2.0) and LOD (0.01 ng/mL).
Dobutamine, a β-adrenergic receptor agonist, is used in treating heart failure and other cardiovascular diseases. Impurity 43 may originate from condensation side reactions of arylamines during Dobutamine synthesis. The polymethoxyphenyl group in its structure may affect drug stability and efficacy. With stricter FDA requirements for cardiovascular drug impurity control, studying such process impurities is key to ensuring drug quality.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 2.5 minutes, with LOD of 0.002 ng/mL for trace analysis.
Formation Mechanism：Formed by condensation of 4-methoxyaniline with 3,4-dimethoxyphenethyl halide under alkaline conditions; optimizing reaction time (≤4h) and solvent polarity (e.g., acetonitrile-water system) inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 187.5 μM against H9c2 cardiac cells (Dobutamine IC₅₀=15.6 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing for degradation monitoring.
This product is intended for laboratory use only!
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E-mail: anna@molcoo.com
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