Dobutamine Impurity

Product Information

• Product Code：D044044

• English Name：Dobutamine Impurity 44

• English Alias：2-(3-hydroxy-4-methoxyphenyl)acetonitrile

• CAS No.：4468-58-0

• Molecular Formula：C?H?NO?

• Molecular Weight：163.17

Advantages

• 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.

Applications

• Quality Control Testing：Used for HPLC and LC-MS detection of Impurity 44 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 cyanidation temperature (e.g., 25-30℃) and cyanide reagent dosage.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying HPLC resolution (≥2.0) 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 achieves separation within 2 minutes, with LOD of 0.002 ng/mL for trace analysis.

• Formation Mechanism：Formed by reaction of 3-hydroxy-4-methoxybenzaldehyde with sodium cyanide under alkaline conditions; optimizing reaction pH (8.0-9.0) and time (≤3h) inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 205.6 μM against H9c2 cardiac cells (Dobutamine IC??=15.6 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing for degradation monitoring.

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!

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E-mail: anna@molcoo.com

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