Cyanocobalamin CAS 68-19-9 — China API Manufacturer | ChP/USP/EP/JP R&D to Production

Product Overview & China Manufacturing Landscape

Cyanocobalamin (Vitamin B12) is an essential water-soluble vitamin required for neurological function, DNA synthesis, and red blood cell formation, used pharmaceutically for treating pernicious anemia and vitamin B12 deficiency, and extensively in food fortification and dietary supplements. With CAS number 68-19-9 and molecular formula C₆₃H₈₈CoN₁₄O₁₄P, cyanocobalamin is one of the most structurally complex non-polymeric natural products in commercial pharmaceutical production. China dominates global cyanocobalamin manufacturing, accounting for over 90% of worldwide production with approximately 10-12 major producers and combined annual capacity exceeding 50 metric tons of pure cyanocobalamin. Our facility in Hebei Province operates within China’s premier vitamin B12 production cluster, where specialized fermentation expertise and supporting infrastructure have been developed over three decades.

Our Manufacturing Process & Facility Standards

Cyanocobalamin production is exclusively by microbial fermentation, using optimized strains of Pseudomonas denitrificans in large-scale aerobic fermentation. Our fermentation facility operates bioreactors up to 300,000 liters, running controlled 6-8 day fermentation cycles under precise dissolved oxygen, temperature, and pH management. Post-fermentation processing involves cell disruption, cyanide addition for conversion of various cobalamin forms to the stable cyanocobalamin, multi-stage chromatographic purification (ion exchange and reverse phase), and final crystallization from aqueous acetone. Our quality-controlled production facility provides 20,000 square meters of manufacturing space, with ISO 14644-1 Class 7 cleanroom environments for purification, crystallization, and packaging operations. In-process controls include HPLC potency monitoring throughout purification, UV-Vis spectrophotometric analysis (characteristic absorbance ratio A361/A550), cyanide content verification, and microbiological contamination monitoring of fermentation. Our process consistently achieves batch-to-batch assay RSD below 1.0% across annual production of 8+ metric tons of pure crystalline cyanocobalamin.

Quality Standards & Multi-Pharmacopeial Compliance

Our cyanocobalamin meets all major pharmacopeial standards: ChP 2020, USP-NF, EP 11.0, JP XVIII, and BP. Typical assay values are 96.0-102.0% on a dried basis (per USP/EP range for this complex molecule). Quality control parameters include: UV absorbance ratios confirming molecular identity and purity, related substances by HPLC (total impurities ≤1.5%), loss on drying (≤12.0%), cyanide content within specified range, residual solvents per ICH Q3C, heavy metals (cobalt content within theoretical range, other metals ≤10 ppm), and complete microbial limits testing. For food-grade applications, additional testing includes pesticide residues, aflatoxins, and GMO status documentation (non-GMO fermentation organism). We produce cyanocobalamin in multiple concentration grades: pure crystalline (≥96% pharmaceutical grade), and standardized dilutions (0.1%, 1.0%) on approved carriers for food and supplement applications. Complete COA documentation with full analytical data accompanies every shipment.

Regulatory Documentation & Registration Support

Our cyanocobalamin regulatory portfolio covers both pharmaceutical and food/supplement regulatory frameworks worldwide. Pharmaceutical documentation includes: NMPA drug registration certificate, US FDA Type II DMF, European CEP from EDQM, Japanese DMF, WHO prequalification, and quality certificates from Chinese and international authorities. For food and supplement markets: US FDA GRAS status, EU Novel Food compliance, FSSAI registration for India, and Kosher/Halal certifications. Our facility holds FDA establishment registration and has been inspected by US FDA, EU member state inspectorates, WHO prequalification team, and PMDA with successful outcomes. Additionally, we maintain ISO 22000 and FSSC 22000 certifications for food safety management. Our regulatory team supports customers across pharmaceutical, food, and supplement channels with market-specific documentation packages and registration strategy guidance for over 30 countries.

Packaging, Storage & Global Logistics

Cyanocobalamin is a light-sensitive compound, and packaging is designed accordingly. Pure crystalline material is packaged in amber glass bottles or double-layer aluminum foil bags within lightproof drums. Standard pharmaceutical packaging sizes include 100 g, 500 g, 1 kg, and 5 kg. Standardized dilutions are packaged in 5 kg, 10 kg, and 25 kg drums. Storage conditions require temperatures below 25°C in a dry, light-protected environment with validated shelf life of 36 months. Our logistics team ships cyanocobalamin globally to over 70 countries, utilizing sea freight (20-35 days), rail (14-18 days to Europe), and air freight (3-7 days). All packaging includes light protection validation, and shipments to tropical climates include temperature monitoring. Complete export documentation — including commercial invoices, COA, certificates of origin, free sale certificates, and pharmaceutical product certificates — is prepared by our experienced documentation team within 2 business days of order confirmation.

Competitive Pricing & Supply Reliability

As one of the world’s largest cyanocobalamin producers, our fermentation scale and integrated purification capabilities deliver the most competitive pricing globally. Manufacturer-direct supply eliminates multiple distribution layers, typically providing 40-55% savings compared to Western-sourced cyanocobalamin. MOQ is 1 kg for pharmaceutical-grade evaluation (pure crystalline), 25 kg for standardized dilutions, and 100 kg for food-grade bulk orders. We offer quarterly pricing linked to fermentation feedstock costs, annual fixed-price contracts, and special pricing for institutional and government procurement. Our production capacity of 8+ metric tons pure crystalline cyanocobalamin annually ensures reliable supply with no allocation constraints. We maintain strategic finished product inventory of 1+ metric ton for immediate availability and fermentation raw material reserves for 6 months of continuous production. Long-term supply agreements with guaranteed pricing and allocation are standard for key accounts.

Product Specifications