Understanding the Specifications of (R)-1-Aminoindane Hydrochloride for API Synthesis
For Active Pharmaceutical Ingredient (API) manufacturers, understanding the detailed specifications of their raw materials and intermediates is crucial for ensuring product quality, consistency, and regulatory compliance. (R)-1-Aminoindane Hydrochloride, a key intermediate in the synthesis of Rasagiline Mesylate for Parkinson's disease treatment, is no exception. NINGBO INNO PHARMCHEM CO.,LTD. provides a comprehensive overview of the essential specifications for this vital chemical compound.
The typical appearance of high-quality (R)-1-Aminoindane Hydrochloride is an off-white to white powder. This physical characteristic is an initial indicator of purity, though further analytical testing is always necessary. The most critical specification is the assay, which quantifies the amount of the desired compound present. For (R)-1-Aminoindane Hydrochloride, an assay of ≥99.0% by High-Performance Liquid Chromatography (HPLC) is standard, ensuring a high degree of chemical purity. When you buy (R)-1-Aminoindane Hydrochloride, verifying this assay is a primary step.
Melting point is another important physical property that serves as an indicator of purity. For (R)-1-Aminoindane Hydrochloride, a specific melting point range, often cited between 232-234°C or 238-242°C depending on the source and purity, is expected. Deviations from this range can suggest the presence of impurities. The moisture content is also carefully controlled, typically specified as ≤0.5%, as excess moisture can affect stability and reactivity.
Impurity profiling is perhaps one of the most rigorous aspects of specification control. Pharmaceutical intermediates must adhere to strict limits on individual and total impurities. For (R)-1-Aminoindane Hydrochloride, a single impurity limit might be set at ≤0.3%, with total impurities not exceeding 1.0%. These limits are vital because even small amounts of impurities can interfere with downstream reactions, affect the potency of the final API, or introduce safety concerns. Therefore, sourcing this R-1-Aminoindane Hydrochloride pharmaceutical intermediate from manufacturers with robust impurity control is essential.
NINGBO INNO PHARMCHEM CO.,LTD. is committed to meeting and exceeding these critical specifications. We understand that our R-1-Aminoindane Hydrochloride is not just a chemical; it's a building block for therapies that improve human health. By ensuring that our R-1-Aminoindane Hydrochloride intermediate for Rasagiline Mesylate synthesis consistently meets these demanding standards, we empower our clients to produce APIs of the highest caliber. This detailed attention to specifications is a core part of our commitment to quality in the pharmaceutical supply chain.
In summary, a thorough understanding and adherence to the specifications of (R)-1-Aminoindane Hydrochloride are fundamental for successful API manufacturing. NINGBO INNO PHARMCHEM CO.,LTD. provides a reliable source for this essential R-1-Aminoindane Hydrochloride intermediate, ensuring that manufacturers have access to material that meets stringent appearance, assay, melting point, moisture, and impurity requirements for their Rasagiline Mesylate synthesis.
Perspectives & Insights
Data Seeker X
“When you buy (R)-1-Aminoindane Hydrochloride, verifying this assay is a primary step.”
Chem Reader AI
“Melting point is another important physical property that serves as an indicator of purity.”
Agile Vision 2025
“For (R)-1-Aminoindane Hydrochloride, a specific melting point range, often cited between 232-234°C or 238-242°C depending on the source and purity, is expected.”