Dobutamine EP Impurity C(Hydrobromide) NEW

Dobutamine EP Impurity C(Hydrobromide)

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E-mail: anna@molcoo.com.

• Product Information

• Product Number: D044002B

• English Name: Dobutamine EP Impurity C(Hydrobromide)

• English Alias: N-(3,4-dimethoxyphenethyl)-4-(4-methoxyphenyl)butan-2-amine hydrobromide

• CAS Number: None

• Molecular Formula: C₂₁H₂₉NO₃·HBr

• Molecular Weight: 424.37（343.46 + 80.91）

• Advantages

• As an EP impurity reference standard (hydrobromide form) for dobutamine, this compound has the following advantages:
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• Well-defined structure and stable salt form, enabling analysis of by-product formation mechanisms during dobutamine synthesis, such as benzene ring substitution and amination reactions, to optimize processes and control impurity generation;

• As a salt-form reference standard containing polymethoxybenzene rings and amino groups, it provides a stable quantitative standard for HPLC, LC-MS, and other detection methods, improving method accuracy;

• The hydrobromide form enhances water solubility, facilitating simulation of impurity behavior in physiological environments during formulation stability studies.

• Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity C in dobutamine preparations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity and specificity of detection methods (e.g., HPLC or LC-MS), ensuring compliance with EP pharmacopoeia requirements;

• Stability Studies: Investigating the degradation behavior of hydrobromide under acidic/alkaline conditions to evaluate its impact on dobutamine injection stability.

• Background Description

• Dobutamine is a β-adrenergic receptor agonist used for treating heart failure. During its synthesis, incomplete methoxylation reactions or abnormal amino substitution positions easily generate impurities containing polymethoxybenzene rings. As an impurity controlled by the EP pharmacopoeia, research on this hydrobromide impurity is a key part of dobutamine quality control, especially in injectable formulations where its content must be strictly controlled to ensure medication safety.

• Research Status

• Current research focuses on:
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• Detection Method Optimization: Establishing trace detection methods using UPLC-MS/MS technology, leveraging the ionization characteristics of hydrobromide to enhance mass spectrometry response sensitivity;

• Synthesis Process Improvement: Reducing by-product generation by optimizing the catalyst (such as palladium carbon) and reaction temperature of methoxylation reactions;

• Salt Form Stability: Studying the hygroscopicity and degradation pathways of hydrobromide under high temperature and humidity conditions to provide data for storage conditions;

• Toxicological Evaluation: Evaluating the potential impact of this impurity on cardiac muscle cells through in vitro cytotoxicity experiments to assist in setting safe limits

This product is intended for laboratory use only!

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