Trilostane 13647-35-3 — China API Manufacturer | USP/EP R&D to Production

China Manufacturing Landscape for Trilostane

Trilostane (CAS 13647-35-3) is a synthetic steroid analogue that acts as a competitive inhibitor of 3β-hydroxysteroid dehydrogenase, used primarily in veterinary medicine for the treatment of hyperadrenocorticism (Cushing’s disease) in dogs and historically in human medicine for breast cancer and Cushing’s syndrome. Marketed as Vetoryl in the veterinary pharmaceutical market, Trilostane API demand has grown steadily alongside increasing companion animal healthcare spending. Chinese manufacturers, including our production facility, have developed efficient synthetic routes for Trilostane that use China’s deep expertise in steroid chemistry to provide the global veterinary pharmaceutical industry with a reliable, cost-effective API source.

China’s steroid synthesis industry represents one of the country’s most mature pharmaceutical manufacturing sectors, with extensive capabilities spanning plant steroid extraction, chemical transformation, and multi-step total synthesis of complex steroidal structures. Our facility draws upon this deep industry knowledge base, specialized equipment infrastructure, and experienced chemistry workforce to manufacture Trilostane at scale with consistent quality and competitive economics.

Manufacturing Process & Facility

Trilostane synthesis employs a semi-synthetic approach starting from readily available steroidal precursors, with key transformations including selective epoxidation at the 4,5-position, introduction of the 2α-cyano group through stereoselective cyanation chemistry, and functional group manipulations to establish the required 3-keto-4α,5α-epoxy-17β-hydroxy substitution pattern on the androstane skeleton. Stereochemical control at each modification step is critical and is achieved through optimized reagent selection, reaction temperature control, and use of directing groups where appropriate.

The production facility features specialized steroid chemistry equipment including glass-lined reactors with precise temperature control (-40°C to +200°C), chromatographic purification systems (both column and preparative HPLC), and crystallization vessels engineered for controlled nucleation and crystal growth. Dedicated analytical laboratories support in-process monitoring of stereochemical outcomes at each synthetic step. The facility operates under NMPA certification with annual Trilostane production capacity of 500 kg, expandable to 1,500 kg through validated process scale-up.

Quality Standards & Multi-Pharmacopeial Compliance

Our Trilostane API is manufactured to meet USP and EP pharmacopeial standards applicable to veterinary pharmaceutical APIs. HPLC purity consistently exceeds 99.0%, with critical stereoisomeric impurities including the 4β,5β-epoxide diastereomer controlled below 0.5%. Assay by validated HPLC method confirms potency within 98.0-102.0% of label claim. Identity is verified by IR spectroscopy, specific optical rotation measurement, and HPLC retention time comparison against qualified reference standards.

Complete testing includes HPLC purity and related substances, stereoisomer content by chiral HPLC, residual solvents by headspace GC, elemental impurities by ICP-MS, loss on drying, sulfated ash, particle size distribution, and microbial limits testing. All analytical methods are validated per ICH Q2(R1) guidelines. Stability studies under ICH-aligned conditions demonstrate a validated shelf life of 36 months when stored under recommended conditions.

Regulatory Documentation

We provide complete regulatory documentation packages tailored for veterinary pharmaceutical registrations across major markets. Documentation includes Veterinary Drug Master Files (VDMF), CTD-V formatted manufacturing process descriptions, full analytical method validation reports, batch analysis reports, impurity qualification data, and stability data packages. quality certificates from NMPA, manufacturing authorization documentation, and quality management system certificates are provided as standard. Our regulatory affairs team provides direct support for customer registration activities, including preparation of responses to regulatory authority queries and provision of additional data packages as requested during the review process.

Packaging & Logistics

Trilostane API is packaged in pharmaceutical-grade double PE bags within aluminum-lined fiber drums, available in 1 kg, 5 kg, and 25 kg configurations. All packaging materials are validated for compatibility and stability. The product is shipped at controlled room temperature via air freight for standard international delivery within 5-10 business days, or via sea freight for bulk orders with transit times of 20-35 days. Complete export documentation is provided including CoA, MSDS, quality certificate, veterinary health certificate, and customs clearance support. We support FOB, CIF, and DDP shipping terms.

Competitive Pricing & Supply Reliability

Direct competitive pricing for Trilostane benefits from our efficient steroid synthesis platform and vertically integrated supply chain. We offer competitive pricing with volume-based discounts for annual purchase agreements, project-specific quotations for formulation development quantities, and strategic pricing for multi-year commitment arrangements. Standard lead times are 4-6 weeks for confirmed orders, with the ability to accommodate urgent requirements within 2-3 weeks from maintained intermediate inventory. Our supply planning system coordinates production campaigns with customer demand forecasts to optimize delivery scheduling and minimize working capital burden for both parties.

Trilostane Specifications