Technical Specification and Quality Assurance for CAS 143612-79-7

• High-Purity Specification: Delivered with ≥99% industrial purity suitable for critical API synthesis.
• Regulatory Compliance: Full documentation support including COA and adherence to GMP standard protocols.
• Global Supply Chain: Reliable bulk procurement with controlled storage and shipping conditions.

The pharmaceutical industry demands rigorous consistency when sourcing complex heterocyclic building blocks. 3-(4-Chlorobutyl)-1H-indole-5-carbonitrile, identified by CAS 143612-79-7, serves as a critical Vilazodone intermediate in the production of antidepressants targeting 5-HT receptors. As a key indole derivative, this compound requires precise handling to maintain structural integrity during the manufacturing process. At NINGBO INNO PHARMCHEM CO.,LTD., we prioritize technical transparency, ensuring that every batch meets the stringent requirements necessary for downstream API manufacturing.

The molecular formula C13H13ClN2 and molecular weight of 232.71 g/mol define the physical parameters of this substance. However, commercial viability depends heavily on the removal of side products and unreacted precursors. Our production facilities utilize optimized synthesis route methodologies to maximize reaction yields while minimizing impurities. This focus on industrial purity ensures that procurement teams can rely on consistent performance during scale-up phases without unexpected variations in reaction kinetics.

Comprehensive Documentation Beyond Standard Certificate of Analysis

Obtaining a basic COA is merely the starting point for qualified procurement. True Quality assurance involves a complete data package that traces the material from raw material intake to final packaging. For CAS 143612-79-7, documentation must include detailed impurity profiles, residual solvent analysis, and heavy metal testing. Buyers evaluating bulk price propositions must consider the value of this comprehensive data, as it reduces the risk of regulatory delays during drug master file (DMF) submissions.

Our documentation protocols exceed standard industry expectations. Each batch is assigned a unique lot number linked to full manufacturing records. This traceability is essential for audits and ensures that any query regarding the material history can be resolved immediately. When sourcing high-purity 3-(4-Chlorobutyl)-1H-indole-5-carbonitrile, buyers should verify that the supplier provides stability data and recommended storage conditions. Our standard protocol dictates storage at +4°C to prevent degradation, while shipping is conducted at room temperature under validated conditions to ensure thermal stability during transit.

Parameter	Specification	Test Method
Appearance	Off-white to Light Yellow Solid	Visual
Purity (HPLC)	≥ 99.0%	Area Normalization
Identification	Conforms to Structure	IR / NMR
Loss on Drying	≤ 0.5%	Karl Fischer / LOD
Residual Solvents	Complies with ICH Q3C	GC

HPLC and NMR Verification Protocols for Batch Consistency

Analytical verification is the cornerstone of maintaining batch-to-batch consistency. For this specific pharmaceutical building block, High-Performance Liquid Chromatography (HPLC) is employed to quantify the main peak and identify related substances. The method is validated to ensure linearity, accuracy, and precision across the expected concentration range. Nuclear Magnetic Resonance (NMR) spectroscopy provides structural confirmation, ensuring that the chlorobutyl chain is correctly attached to the indole ring at the 3-position and that the carbonitrile group remains intact at the 5-position.

Variations in the synthesis route can lead to regioisomers or chlorination byproducts that are difficult to separate later in the API process. Our global manufacturer facilities utilize standardized analytical methods that align with international pharmacopoeial standards. This alignment simplifies the technology transfer process for clients developing generic or novel formulations. By maintaining strict control over the analytical profile, we ensure that the material performs predictably in subsequent coupling or reduction reactions required for Vilazodone synthesis.

Regulatory Compliance for Downstream API Manufacturing

Compliance with regulatory frameworks is non-negotiable for intermediates destined for human therapeutics. Adherence to a GMP standard ensures that the manufacturing environment is controlled, clean, and documented. While this intermediate may not always require full API-level GMP certification depending on the step of synthesis, operating under GMP-like conditions significantly reduces contamination risks. This proactive approach supports clients in meeting their own regulatory obligations when filing IND or NDA applications.

Supply chain security is another critical aspect of compliance. As a leading global manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. maintains robust inventory levels to prevent shortages that could disrupt client production schedules. We understand that the availability of critical intermediates like CAS 143612-79-7 directly impacts the time-to-market for finished dosage forms. Our quality management system is designed to handle audits from international regulatory bodies, providing clients with the confidence needed for long-term partnerships.

Compliance Feature	Implementation	Benefit
Quality Management System	ISO 9001 Certified	Consistent Process Control
Documentation	Full Batch Records	Complete Traceability
Testing	In-house QC Lab	Rapid Release Times
Storage	Climate Controlled	Product Stability

In conclusion, the selection of a supplier for CAS 143612-79-7 should be based on technical capability and regulatory support rather than cost alone. The integration of advanced analytical protocols, comprehensive documentation, and strict adherence to quality standards defines a reliable partnership. By choosing a supplier committed to Quality assurance and GMP standard practices, pharmaceutical companies can mitigate risk and ensure the successful commercialization of their final products.