Lomustine 13010-47-4 — China API Manufacturer | EP USP R&D to Production

China Manufacturing Landscape for Lomustine

Lomustine (CAS 13010-47-4), also known as CCNU, is a nitrosourea alkylating agent used in the chemotherapy treatment of brain tumors (including glioblastoma multiforme), Hodgkin lymphoma, and other malignancies. As an orally bioavailable alkylating agent with the ability to cross the blood-brain barrier, Lomustine occupies a unique therapeutic niche in oncology. China has developed specialized manufacturing capabilities for this cytotoxic compound, and our production facility provides pharmaceutical companies with a reliable source of high-purity Lomustine API for capsule formulation and other applications.

The manufacture of nitrosourea compounds requires specialized handling expertise and rigorous safety protocols due to their chemical reactivity and potent biological activity. Our facility has made targeted investments in containment infrastructure, process engineering, and analytical capabilities to produce Lomustine consistently and safely, serving the global generic oncology market with competitive manufacturer-direct supply.

Manufacturing Process & Facility Overview

Lomustine production at our facility involves the nitrosation of 1-(2-chloroethyl)-3-cyclohexylurea under carefully controlled conditions to introduce the N-nitroso functional group characteristic of the nitrosourea drug class. The synthesis requires precise temperature control throughout the nitrosation step (maintained below 0°C) to prevent decomposition and ensure high yield. The crude product undergoes multi-stage purification including recrystallization and chromatographic treatment to achieve pharmacopeial purity specifications.

The HPAPI manufacturing suite features cryogenic reaction capability, negative pressure containment with OEL controls, isolator technology for powder handling operations, and validated decontamination systems. The facility operates under full pharmaceutical compliance with environmental monitoring, personnel protection programs including health surveillance, and complete waste management systems for nitrosourea-containing waste streams. Production is conducted in dedicated campaign mode with validated changeover procedures between products.

Quality Standards & Multi-Pharmacopeial Compliance

Our Lomustine API meets the quality specifications defined in European Pharmacopoeia (EP) and United States Pharmacopeia (USP) monographs. The complete analytical program includes assay by validated HPLC method (purity ≥98.0%), identification by IR spectroscopy and HPLC, related substances analysis including monitoring of the des-nitroso impurity and the cyclohexyl isocyanate degradation product, melting point determination, loss on drying, residue on ignition, and heavy metals testing.

Given the thermal instability of nitrosourea compounds, our quality program includes accelerated and stressed stability studies with tight degradation monitoring, and all analytical methods have been validated to be stability-indicating. The QC laboratory operates specialized HPLC methods with UV and nitrogen-specific detection for complete impurity profiling. Storage conditions and shelf-life assignments are based on extensive real-time stability data.

Regulatory Documentation & Export Support

We provide complete regulatory documentation to support customer drug registration and import processes worldwide. Our documentation package includes Drug Master File (DMF) documentation, batch-specific Certificates of Analysis, MSDS/SDS in GHS format, ICH-compliant stability data packages, process validation documentation, and analytical method validation reports. Additional technical data including forced degradation study results, impurity characterization data, and cleaning validation documentation is available upon request.

Our regulatory team supports customer filing activities for Lomustine formulations across regulated and emerging markets, providing timely responses to regulatory queries and post-approval variation documentation as needed.

Packaging & Global Logistics

Lomustine API is packaged in amber glass bottles with PTFE-lined closures, sealed under nitrogen atmosphere, and packed in secondary containers with cold pack protection. Standard packaging units include 50 g, 100 g, 500 g, and 1 kg configurations. All packaging operations are conducted within containment isolators under controlled temperature conditions to prevent thermal degradation and ensure operator safety. Each container carries complete lot traceability and hazard communication labeling.

Temperature-controlled shipping (2-8°C) is mandatory for Lomustine to maintain product stability during transit. International shipments are coordinated through specialized pharmaceutical cold chain logistics providers, with continuous temperature monitoring via calibrated data loggers. We offer FOB, CIF, and DDP terms with air freight as the primary shipping mode, achieving delivery within 3-5 business days to most destinations globally.

Competitive Pricing & Supply Reliability

Our specialized HPAPI manufacturing capabilities and optimized synthesis processes enable competitive competitive pricing for Lomustine API. We provide transparent pricing with consideration for order volume, contract duration, and customer commitment levels. Development-stage pricing supports early formulation work, while commercial pricing structures offer cost advantages that scale with procurement volume.

Supply security is maintained through planned production campaigns, strategic intermediate stockpiling, and maintained finished goods inventory under validated cold storage conditions. Our oncology API supply track record demonstrates reliable on-time delivery performance exceeding 95%, with dedicated account management ensuring responsive communication and proactive supply planning.

Lomustine Technical Specifications