The Chemical Profile of 1-Methylazepan-4-one HCl for API Synthesis
The journey from raw materials to finished pharmaceutical products is a complex chain, with each link playing a crucial role in the final outcome. For the synthesis of Azelastine Hydrochloride, a key antihistamine, the intermediate 1-Methylazepan-4-one Hydrochloride (CAS No. 19869-42-2) stands out as a critical component. Its chemical profile, including its physical and chemical properties, purity standards, and handling requirements, is of immense interest to chemical manufacturers and pharmaceutical developers alike. Understanding this profile is fundamental to efficient API production.
1-Methylazepan-4-one Hydrochloride is characterized by its molecular formula C7H14ClNO and a molecular weight of 163.645 g/mol. Physical properties commonly reported include its appearance as a yellow-brown powder, with a melting point range of 115-120°C. These physical attributes are important for identification and handling. More critical for its application as a pharmaceutical intermediate are its purity metrics. Specifications typically demand an assay of ≥95.0%, indicating a high concentration of the active compound. Furthermore, the control of impurities is paramount; limits are usually set for single impurities (≤1.5%) and total impurities (≤5.0%). These stringent controls are not arbitrary; they ensure that the intermediate contributes optimally to the synthesis of Azelastine Hydrochloride without introducing undesirable side products that could compromise the safety or efficacy of the final API.
For pharmaceutical companies looking to order this intermediate, partnering with a reliable manufacturer is essential. A high-quality supplier will not only provide material that meets these precise specifications but also offer consistent batch-to-batch quality. This consistency is vital for reproducible synthesis processes and for meeting regulatory standards like Good Manufacturing Practices (GMP). When engaging with potential suppliers, it is advisable to request detailed technical data sheets (TDS) and sample Certificates of Analysis (CoA) to verify compliance with your specific requirements. The availability of Material Safety Data Sheets (MSDS) is also crucial for safe handling and storage protocols.
The utility of 1-Methylazepan-4-one Hydrochloride is primarily as an intermediate in the synthesis of Azelastine Hydrochloride. This means its primary market lies with API manufacturers and contract research organizations (CROs) involved in pharmaceutical development. The availability of this intermediate in common industrial pack sizes, such as 25 kg drums, facilitates its integration into larger-scale production workflows. Therefore, when exploring options to buy this chemical, consider the supplier's capacity to fulfill these industrial requirements and their ability to offer competitive wholesale prices.
In summary, the chemical profile of 1-Methylazepan-4-one Hydrochloride is a testament to its importance as a pharmaceutical intermediate. Its well-defined physical and chemical properties, coupled with rigorous purity standards, make it a cornerstone in the synthesis of Azelastine Hydrochloride. Pharmaceutical professionals seeking this compound should prioritize sourcing from reputable manufacturers and suppliers who can guarantee both quality and consistency, ensuring the integrity of their final API products.
Perspectives & Insights
Bio Analyst 88
“In summary, the chemical profile of 1-Methylazepan-4-one Hydrochloride is a testament to its importance as a pharmaceutical intermediate.”
Nano Seeker Pro
“Its well-defined physical and chemical properties, coupled with rigorous purity standards, make it a cornerstone in the synthesis of Azelastine Hydrochloride.”
Data Reader 7
“Pharmaceutical professionals seeking this compound should prioritize sourcing from reputable manufacturers and suppliers who can guarantee both quality and consistency, ensuring the integrity of their final API products.”