Carmustine CAS 154-93-8 — China API Manufacturer | USP/EP R&D to Production

Product Overview & China Manufacturing Landscape

Carmustine (BCNU, bis-chloroethylnitrosourea) is an alkylating antineoplastic agent used in the treatment of brain tumors, Hodgkin’s lymphoma, non-Hodgkin’s lymphomas, and multiple myeloma. With CAS number 154-93-8 and molecular formula C₅H₉Cl₂N₃O₂, carmustine is unique among nitrosoureas for its ability to cross the blood-brain barrier, making it essential in CNS oncology protocols. Due to its classification as a cytotoxic substance, carmustine API manufacturing requires specialized containment facilities that limit the number of qualified global producers. China has approximately 4-5 NMPA-registered manufacturers with appropriate high-potency API (HPAPI) handling capabilities, with combined annual capacity around 2-3 metric tons. Our facility operates one of the most advanced cytotoxic API production platforms in China, with full containment capabilities up to OEB Level 5.

Our Manufacturing Process & Facility Standards

Carmustine synthesis proceeds via nitrosation of 1,3-bis(2-chloroethyl)urea under carefully controlled temperature and pH conditions. Despite the apparently simple chemistry, the process demands extreme precision due to carmustine’s thermal instability and decomposition above 30°C. Our dedicated cytotoxic API manufacturing suite features full negative-pressure containment with HEPA-filtered exhaust, isolator technology for material handling, and ISO 14644-1 Class 6 cleanroom environments throughout. All reaction stages maintain temperatures below 5°C using cryogenic cooling systems. The crystallization and drying stages utilize vacuum conditions at temperatures not exceeding -20°C to prevent decomposition. In-process controls include continuous temperature monitoring with ±0.5°C precision, nitrosamine content verification, decomposition product screening by HPLC, and operator exposure monitoring by surface wipe sampling. Our manufacturing personnel undergo specialized HPAPI training and utilize powered air-purifying respirators (PAPRs) and full body protection. Typical batch sizes are 5-15 kg with cycle times of 5-7 days.

Quality Standards & Multi-Pharmacopeial Compliance

Our carmustine API is manufactured to meet USP-NF and European Pharmacopoeia (EP 11.0) specifications. Typical assay values are 98.0-101.0% on an anhydrous basis. Quality control for this thermally labile compound requires specialized protocols: related substances analysis by HPLC maintained below pharmacopeial limits (total impurities ≤2.0%), residual solvents with particular attention to Class 1 solvents, water content (≤0.5% by Karl Fischer), heavy metals (≤20 ppm), and specific decomposition products unique to nitrosourea chemistry. Due to the cytotoxic nature, all QC testing is conducted in dedicated containment laboratories with isolated HVAC systems. Stability testing follows ICH Q1A guidelines with storage at -20°C demonstrating 24-month shelf life. Accelerated stability data at 5°C and 25°C are available to support customer formulation development. Every shipment includes a detailed COA with batch-specific stability data points.

Regulatory Documentation & Registration Support

Given the specialized nature of carmustine manufacturing, our regulatory portfolio is designed to address both product quality and occupational safety aspects required by international regulatory authorities. Available documentation includes: NMPA drug registration certificate, US FDA Type II DMF, European ASMF for customer CEP referencing, current quality certificate with cytotoxic manufacturing scope, and occupational exposure limit (OEL) determination reports. Our facility has undergone specialized HPAPI-focused audits from European qualified persons and US pharmaceutical companies with favorable outcomes. Regulatory support services include CTD Module 3.2.S documentation with emphasis on the stability and handling sections critical for this compound, containment validation reports for cross-contamination risk assessment, and cleaning validation data demonstrating residue control to ng/cm² levels. We support customer engagement with regulatory authorities for oncology product filings worldwide.

Packaging, Storage & Global Logistics

Carmustine API requires specialized cold chain packaging reflecting its thermal sensitivity. Each unit is packaged under nitrogen in amber glass bottles with PTFE-sealed closures, placed into insulated containers with dry ice. Standard packaging sizes are 100 g, 500 g, and 1 kg. Outer packaging includes cytotoxic hazard labeling per GHS and IATA regulations. Storage must maintain -20°C or below at all times, with continuous temperature monitoring. All shipments use validated cold chain logistics with redundant dry ice capacity calculated for worst-case transit duration plus 48-hour contingency. We ship exclusively via air freight using IATA-compliant dangerous goods packaging (UN3249, Class 6.1). Typical delivery time is 3-7 days door-to-door to major global destinations. Temperature data loggers with immediate excursion alerting are included in every shipment. Our logistics team holds IATA DG certification and handles all hazmat documentation.

Competitive Pricing & Supply Reliability

Carmustine is a high-value niche API, and our pricing reflects the specialized containment facilities, cold chain requirements, and limited global supplier base. Nevertheless, our China-based manufacturing delivers significant cost advantages — typically 35-50% below European cytotoxic API manufacturers for comparable quality and containment standards. MOQ is 100 g for evaluation, with commercial orders from 500 g. Annual consumption for most customers ranges from 2-20 kg, and we offer annual supply contracts with quarterly delivery schedules and fixed pricing. Our production capacity supports monthly output of 50-100 kg when operating at full utilization. Given the specialized nature of this product, we recommend customers place orders 60-90 days in advance of required delivery. Strategic raw material inventory covers 8+ months of production, and our containment facility operates year-round without seasonal shutdowns.

Product Specifications