Benazepril CAS 86541-75-5 — China API Manufacturer | USP/EP/ChP R&D to Production

Product Overview & China Manufacturing Landscape

Benazepril is an angiotensin-converting enzyme (ACE) inhibitor prodrug used in the treatment of hypertension and congestive heart failure, converting to its active metabolite benazeprilat in vivo. With CAS number 86541-75-5 and molecular formula C₂₄H₂₈N₂O₅, benazepril represents a critical cardiovascular API with growing global demand driven by increasing hypertension prevalence. China has approximately 10 NMPA-registered manufacturers of benazepril API, with combined annual production capacity of around 150 metric tons. Our manufacturing operation is situated in Zhejiang Province, leveraging the region’s advanced pharmaceutical chemistry infrastructure and proximity to key chiral intermediate suppliers essential for cost-effective production of this stereospecific API.

Our Manufacturing Process & Facility Standards

Benazepril synthesis demands precise stereochemical control, and our process employs an asymmetric synthesis route utilizing chiral pool starting materials to achieve the required (3S)-configuration. The multi-step synthesis involves construction of the octahydro-1H-cyclopenta[b]pyridine core, introduction of the aminoacid moiety via enantioselective methods, and final esterification. Our facility dedicates a specialized 8,000 square meter production suite to ACE inhibitor APIs, featuring ISO 14644-1 Class 7 cleanroom environments, glass-lined and Hastelloy reactors for handling corrosive intermediates, and automated process control systems (DCS/SCADA) for precise temperature and addition rate management. In-process quality controls include chiral HPLC monitoring at three critical stages to verify enantiomeric excess (≥99.0% ee), HPLC assay checks of each intermediate, and inline particle size monitoring during final crystallization. Our batch consistency data across 60+ commercial batches shows assay RSD below 0.9% and enantiomeric purity consistently above 99.5% ee.

Quality Standards & Multi-Pharmacopeial Compliance

Our benazepril API fully complies with USP-NF, European Pharmacopoeia (EP 11.0), and Chinese Pharmacopoeia (ChP 2020) standards. Typical assay values reach 99.5-100.2% on an anhydrous basis. Key quality parameters under strict control include: enantiomeric purity (≥99.0% ee by chiral HPLC), related substances (each specified impurity ≤0.15%, total impurities ≤0.5%), residual solvents (methanol, ethanol, and dichloromethane per ICH Q3C limits), heavy metals (≤10 ppm), water content (≤0.5% by Karl Fischer), and microbial limits. Particle size distribution is characterized by laser diffraction and can be adjusted to meet customer formulation requirements. Every batch undergoes complete testing in our QC laboratory equipped with 15 HPLC systems including chiral columns, ICP-OES for elemental impurity screening per ICH Q3D, and DSC/TGA for thermal characterization. Full COA plus optional method validation transfer packages are provided.

Regulatory Documentation & Registration Support

We maintain a reliable regulatory portfolio for benazepril API including: NMPA drug registration certificate and Chinese DMF, US FDA Type II DMF with active annual updates, European CEP application in progress through EDQM, and current quality certificates from Chinese provincial drug authority. Our manufacturing site holds FDA establishment registration. Supporting documentation available for customer filings includes complete CTD Module 3.2.S dossier, process validation reports, analytical method validation per ICH Q2, impurity fate and purge studies, and ICH Q3D elemental impurity risk assessment. Our regulatory team provides hands-on support for customer registrations in target markets, including preparation of responses to regulatory queries, coordination of pre-approval inspections, and assistance with ASMF/DMF cross-referencing procedures. We have supported customer registrations in the EU, Brazil, Mexico, Egypt, and multiple ASEAN nations.

Packaging, Storage & Global Logistics

Benazepril API is packaged in double-layer polyethylene bags within aluminum drums, providing optimal protection against moisture and light. Standard packaging configurations include 1 kg, 5 kg, and 25 kg units. Storage conditions require controlled room temperature (15-25°C) in a dry environment protected from light, with a validated shelf life of 36 months. We coordinate global shipments through established freight partnerships. Typical transit times are: 28-35 days to European ports by sea, 14-16 days by China-Europe rail, 20-25 days to South American ports, and 4-7 days worldwide by air freight. Temperature monitoring devices are included in shipments upon request. Our logistics team handles all export documentation including commercial invoices, certificates of origin, free sale certificates, MSDS, and customs pre-clearance documentation for major destination markets.

Competitive Pricing & Supply Reliability

Our vertically integrated production of benazepril — from key chiral intermediates through finished API — eliminates dependency on third-party intermediate suppliers and provides a direct cost advantage passed through to our customers. Competitive pricing avoids distributor and trading company markups, typically offering 30-40% savings compared to alternative sources. Minimum order quantity is 25 kg for qualification purposes, with standard commercial orders from 100 kg. We provide quarterly pricing quotations, annual fixed-price contracts for committed volumes, and flexible payment terms for established customers. Our monthly production capacity of 3-5 metric tons provides ample supply for customers of all sizes. Strategic inventory of key starting materials covering 5 months of production, combined with dual-source qualification of critical raw materials, ensures supply continuity under various market conditions.

Product Specifications