Quality Specifications of N-Ethyl-2-Aminomethyl Pyrrolidine: A Deep Dive for Manufacturers
For pharmaceutical manufacturers engaged in the synthesis of Amisulpride, the quality of the raw materials is non-negotiable. N-Ethyl-2-Aminomethyl Pyrrolidine, identified by CAS 26116-12-1, serves as a foundational intermediate, and its specifications directly dictate the success of the downstream processes. NINGBO INNO PHARMCHEM CO., LTD. understands these critical requirements and provides this essential compound with a focus on exceptional quality control.
The primary metric for N-Ethyl-2-Aminomethyl Pyrrolidine is its purity, typically specified as ≥99.0% via Gas Chromatography (GC). This high level of purity is crucial to ensure that the subsequent reactions in the Amisulpride synthesis pathway proceed efficiently and with minimal side reactions. Equally important are the impurity limits: a maximum of ≤0.5% for any single impurity and ≤1.0% for total impurities. Adhering to these limits prevents the introduction of unwanted substances into the API, which can affect its therapeutic efficacy and safety profile. Buyers often search for 'N-Ethyl-2-Aminomethyl Pyrrolidine purity' or 'buy N-Ethyl-2-Aminomethyl Pyrrolidine with low impurities' to ensure they are sourcing from a reliable supplier.
Beyond chemical purity, physical properties and handling also play a significant role. N-Ethyl-2-Aminomethyl Pyrrolidine is a colorless to light-yellow liquid, and its density (0.9±0.1 g/cm3) and boiling point (161.9±0.0 °C at 760 mmHg) are important considerations for process design and scale-up. Proper storage, as recommended – in a cool, ventilated place – is also vital to maintain its integrity. When considering the purchase of this intermediate, manufacturers should inquire about packaging, often provided in 25 kg drums, and confirm adherence to international quality standards.
The consistent availability of N-Ethyl-2-Aminomethyl Pyrrolidine meeting these strict specifications is a cornerstone of efficient Amisulpride production. NINGBO INNO PHARMCHEM CO., LTD. prides itself on delivering intermediates that empower our clients to achieve superior product quality and manufacturing efficiency. By focusing on detailed specifications and rigorous quality control, we support the pharmaceutical industry's need for dependable chemical sourcing.
Perspectives & Insights
Core Pioneer 24
“Buyers often search for 'N-Ethyl-2-Aminomethyl Pyrrolidine purity' or 'buy N-Ethyl-2-Aminomethyl Pyrrolidine with low impurities' to ensure they are sourcing from a reliable supplier.”
Silicon Explorer X
“Beyond chemical purity, physical properties and handling also play a significant role.”
Quantum Catalyst AI
“N-Ethyl-2-Aminomethyl Pyrrolidine is a colorless to light-yellow liquid, and its density (0.”