Hubei Moxin Biotechnology Co., Ltd
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CAS NO.22462-79-9
1(10.0-10000)Metric Ton
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.
5. We can provide a variety of safe ways to transport goods for you to choose.
Methyl heptenone
Product Information
Product Code：H012002
English Name：Heptaminol Hydrochloride EP Impurity A
English Alias：6-methylhept-5-en-2-amine
CAS No.：22462-79-9
Molecular Formula：CHN
Molecular Weight：127.23
Advantages
High-Purity Guarantee：Confirmed by HPLC (≥99.0%), combined with multiple techniques such as NMR (1H, 13C), HRMS, and elemental analysis, providing accurate reference materials for Heptaminol Hydrochloride quality control.
Good Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common organic solvents (such as methanol, acetonitrile) within 6 months, ensuring stable and reliable experimental data.
Applications
Quality Control Testing：Used for UPLC-MS/MS detection of EP Impurity A in Heptaminol Hydrochloride API and formulations, strictly controlling impurity content to meet European Pharmacopoeia (EP) and ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitor the formation pathway of this impurity during Heptaminol Hydrochloride synthesis. Reduce impurity generation by over 50% by adjusting reaction temperature, solvent system, or catalyst type to improve product quality.
Method Validation：Serves as a standard for developing and validating impurity detection methods, ensuring the specificity, sensitivity, and accuracy of the detection methods to meet regulatory requirements for pharmaceutical quality research.
Background Description
Heptaminol Hydrochloride is a drug used to improve cardiac function. During its production, due to raw material residues, side reactions, or improper control of synthesis process conditions, Impurity A (6-methylhept-5-en-2-amine) may be generated. The presence of this impurity may affect the stability, safety, and efficacy of Heptaminol Hydrochloride. With the increasingly strict requirements of global regulatory agencies for drug impurity control, the study and control of Heptaminol Hydrochloride Impurity A have become a key link in ensuring drug quality and patient safety.
Research Status
Detection Technology：UPLC-MS/MS with a C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution achieves separation within 3 minutes, with an LOD as low as 0.002 ng/mL, enabling precise detection of trace impurities.
Formation Mechanism：Studies have shown that this impurity may be generated by isomerization, cyclization, and other side reactions of unsaturated amine substances in raw materials under high temperature or strongly alkaline conditions. Its formation can be effectively inhibited by optimizing the reaction temperature (controlled below 50°C) and using mild alkaline reagents.
Safety Evaluation：In vitro cytotoxicity tests show that the IC of this impurity against H9c2 cardiomyocytes is 168.5 μM (Heptaminol Hydrochloride IC = 12.3 μM). Although less toxic than the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being carried out to systematically monitor its degradation behavior under different humidity, light, and temperature conditions.