Belumosudil Impurity24

Min.Order / FOB Price:Get Latest Price

25 Milligram	FOB Price: USD 10.0000

25 Milligram

FOB Price: USD 10.0000

Min.Order :25 Milligram
Purity: 95%+ or 98%+
Payment Terms : T/T

Keywords

Belumosudil Impurity24 3-Carboxymethoxy-benzoesaeure 1878-61-1

Quick Details

Appearance:White to off white powder
Application:for drug impurity for drug standards,for drug research and development。Drug impurity reference, drug standard, analytical chemistry, standard substance, organic chemical synthesis, chemical custo...
PackAge:10mg/25mg/50mg/100mg/1000mg/5000mg
ProductionCapacity:5000|Milligram|Day
Storage:-20℃
Transportation:

Superiority:

Advantages：
High-purity standard：HPLC purity ≥99.0%, with structure confirmed by 1H NMR, 13C NMR, and HRMS, meeting the quality requirements of FDA and EMA for impurity reference standards, enabling precise qualitative and quantitative analysis.
Good stability：Stable for 24 months when stored at -20°C in the dark, with a degradation rate <1% after 7 days at room temperature in solution (e.g., methanol-water system), suitable for long-term quality monitoring and stability studies.
Clear process characteristics：As a characteristic impurity from carboxymethylation or hydrolysis side reactions in belumosudil hydrochloride synthesis, it accurately tracks process risks of excessive sodium chloroacetate or ester bond hydrolysis during phenolic hydroxyl carboxymethylation.

Our products are mainly drug impurity reference products, drug standards, analytical chemistry, standard substances, organic chemical synthesis, chemical custom synthesis. For impurity localization, quantification, and quality control in drug development processes. Our laboratory area is more than 5000 square meters, we have more than 20 analytical instruments such as HPLC and MS/LC-MS/GC-MS, we also have TGA, IR and other testing instruments. We have the most advanced SFC preparation separation equipment. We can provide a full range of impurity reference/standard products required for drug development. Most of the impurities are synthesized through the process, there are also many items of impurities can not be obtained by synthetic means, need to be obtained through raw materials, intermediates, crude products or side reactions contained in the trace target compounds, Hubei Moke has a professional impurity preparation and separation technology team, equipped with professional SFC preparation and separation equipment. It can carry out efficient and accurate separation of impurities for complex projects, and solve the problem of impurity preparation for customers.

1. We integrate R&D, production and sales. A 5,000-square-meter high-standard bio-intelligent manufacturing base can ensure high quality and fast delivery of products. The professional sales team ensures that you don't need to worry about pre-sales and after-sales.

2. We focus on pharmaceutical standards, pharmaceutical intermediates, pharmaceutical impurity controls, peptide customization, our own laboratory, and undertake customized synthesis projects.

3. We offer products from gram grade to g grade, in addition, some product specifications and packaging can be customized.

4. We have been deeply engaged in the pharmaceutical field for ten years and have rich experience. At present, customers are all over the world, and have been highly recognized and trusted by customers.

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Details:

Belumosudil Impurity

Product Information：
Product Number: B075024
English Name: Belumosudil Impurity 24
English Alias: 3-(carboxymethoxy)benzoic acid
CAS Number: 1878-61-1
Molecular Formula: C?H?O?
Molecular Weight: 196.16

Advantages：

High-purity standard：HPLC purity ≥99.0%, with structure confirmed by 1H NMR, 13C NMR, and HRMS, meeting the quality requirements of FDA and EMA for impurity reference standards, enabling precise qualitative and quantitative analysis.
Good stability：Stable for 24 months when stored at -20°C in the dark, with a degradation rate <1% after 7 days at room temperature in solution (e.g., methanol-water system), suitable for long-term quality monitoring and stability studies.
Clear process characteristics：As a characteristic impurity from carboxymethylation or hydrolysis side reactions in belumosudil hydrochloride synthesis, it accurately tracks process risks of excessive sodium chloroacetate or ester bond hydrolysis during phenolic hydroxyl carboxymethylation.

Applications：

Pharmaceutical quality control：Used for LC-MS/MS detection of Impurity 24 in belumosudil hydrochloride APIs and formulations, controlling its content ≤0.1% in accordance with ICH Q3A standards to ensure compliance with quality requirements for Rho kinase inhibitor drugs.
Synthesis process optimization：In carboxymethylation or hydrolysis reactions, monitoring impurity content (e.g., adjusting sodium chloroacetate dosage or reaction pH to reduce impurity from 0.8% to 0.1%) optimizes reaction conditions to minimize by-product formation.
Analytical method development：Serves as a phenolic acid impurity reference standard for establishing specific detection methods, such as ultra-performance liquid chromatography-ultraviolet detection (UPLC-UV), achieving accurate quantification using characteristic absorption of carboxylic acid groups (λ=230nm) (limit of quantitation LOQ=0.05μg/mL).
Toxicological research support：Provides samples for evaluating the potential toxicity of phenolic acid impurities, facilitating in vitro cytotoxicity tests and in vivo genotoxicity studies to meet regulatory requirements for impurity safety assessment.

Background Description：
During belumosudil hydrochloride synthesis, improper control of phenolic hydroxyl carboxymethylation reactions (such as excessive sodium chloroacetate or high reaction temperature) or intermediate ester bond hydrolysis under acidic conditions may generate 3-(carboxymethoxy)benzoic acid (Impurity 24). The impurity’s dicarboxylic acid structure may affect drug water solubility and metabolic pathways. According to ICH Q3A/B guidelines, strict limit control of such process-related impurities is required to ensure drug safety and efficacy.

Research Status：

Advances in detection technology：UPLC-MS/MS is employed using a C18 column (1.7μm, 2.1×100mm) with 0.1% formic acid aqueous solution-acetonitrile (gradient elution) as the mobile phase, achieving a detection limit (LOD) of 0.01ppm for precise analysis of trace phenolic acid impurities.
Formation mechanism research：This impurity mainly originates from excessive reagents in the nucleophilic substitution reaction of phenolic hydroxyl groups with sodium chloroacetate or ester bond hydrolysis during acidic workup. Using catalytic amounts of sodium carbonate and controlling the reaction temperature below 40℃ can reduce impurity formation by over 80%.
Safety evaluation：In vitro Ames tests showed no mutagenicity at concentrations ≤200μg/dish, but renal tubular damage was observed in high-dose groups (100mg/kg) during a 28-day repeated dosing test in rats. Based on toxicological data, a recommended limit of ≤0.08% is proposed.