Ademetionine Disulfate Tosylate CAS 97540-22-2 — China API Manufacturer | ChP/EP R&D to Production

Product Overview & China Manufacturing Landscape

Ademetionine disulfate tosylate, also known as S-adenosylmethionine (SAMe) disulfate tosylate salt, is a critical API used in hepatoprotective and antidepressant formulations. Bearing CAS number 97540-22-2 and molecular formula C₂₂H₃₄N₆O₁₆S₄, this biologically active methyl donor plays essential roles in transmethylation, transsulfuration, and aminopropylation pathways. China has emerged as one of the leading global producers of ademetionine API, with approximately 8 NMPA-registered manufacturers maintaining combined annual production capacity exceeding 200 metric tons. Our facility employs advanced biotechnological fermentation followed by chemical salt formation, positioning us among the top three Chinese producers by volume. The growing global demand for hepatoprotective APIs, particularly across Asian and Latin American markets, has driven significant capacity expansion in Chinese manufacturing over the past five years.

Our Manufacturing Process & Facility Standards

Our ademetionine disulfate tosylate production employs a proprietary enzymatic biosynthesis route using optimized yeast strains (Saccharomyces cerevisiae) in controlled fermentation, followed by extraction, purification via ion-exchange chromatography, and precise salt formation with p-toluenesulfonic acid and sulfuric acid. The fermentation stage operates in 5,000 L stainless steel bioreactors under strict aseptic conditions. Post-fermentation processing including crystallization and drying takes place in ISO 14644-1 Class 7 cleanroom environments within our 15,000 square meter production facility. Due to the inherent instability of the SAMe molecule, all manufacturing steps are conducted under nitrogen atmosphere with stringent temperature control (2-8°C during critical stages). In-process controls include continuous dissolved oxygen monitoring, real-time HPLC purity checks at extraction and purification stages, and residual solvent analysis by headspace GC. Batch consistency over our last 80 production runs shows assay RSD below 1.5%, demonstrating excellent reproducibility.

Quality Standards & Multi-Pharmacopeial Compliance

Our ademetionine disulfate tosylate API meets Chinese Pharmacopoeia (ChP 2020) and European Pharmacopoeia (EP 11.0) specifications. The USP does not currently include a separate monograph for this salt form; however, we can manufacture to customer-specified standards matching ICH Q6A guidelines. Typical assay values reach 98.5-101.0% on an anhydrous basis. Critical quality parameters include optical rotation ([α]D20 specification per EP), related substances profiling by HPLC (total impurities ≤1.0%), residual solvents per ICH Q3C, water content by Karl Fischer (≤1.0%), heavy metals (≤10 ppm), and microbiological limits testing. The stereochemical purity of the (S,S)-isomer is confirmed at ≥98.0% by chiral HPLC. Each shipment includes a complete COA with full analytical data, plus a certificate of quality compliance. Stability studies following ICH Q1A guidelines confirm a 24-month shelf life under recommended storage conditions.

Regulatory Documentation & Registration Support

Our regulatory portfolio for ademetionine disulfate tosylate includes an active NMPA drug registration certificate, a Chinese DMF, and supporting documentation formatted in CTD Module 3.2.S structure for international submissions. We are currently progressing European CEP application through EDQM and can provide the complete technical dossier to support customer MAA/NDA filings. quality certificates from both Chinese provincial authorities and third-party audit firms (e.g., TÜV SÜD) are available. Our regulatory affairs specialists assist international customers with preparation of technical responses to regulatory queries, organization of site inspection logistics for visiting QPs and regulatory inspectors, and provision of comparability protocols when customers switch API sources. We have supported successful registrations in over 20 countries across Southeast Asia, the Middle East, and South America.

Packaging, Storage & Global Logistics

Given the hygroscopic and oxidation-sensitive nature of ademetionine disulfate tosylate, we employ specialized packaging under nitrogen atmosphere. Each unit is double-sealed in aluminum foil laminate bags within HDPE drums, with oxygen absorber sachets included. Standard configurations are 1 kg, 5 kg, and 10 kg per container. All packaging complies with pharmaceutical-grade contact material regulations. Cold chain logistics are mandatory — storage and transport must maintain 2-8°C throughout. We partner with established cold chain logistics providers including DHL Life Sciences and World Courier for international shipments. Transit times to European destinations average 5-7 days by air freight (recommended) or 30-35 days by refrigerated sea container. Complete shipping documentation including temperature logger data, commercial invoices, and customs declarations are handled by our export team.

Competitive Pricing & Supply Reliability

Ademetionine disulfate tosylate production requires sophisticated biosynthesis capabilities, and our established fermentation platform delivers significant cost efficiencies compared to purely chemical synthesis routes used by some competitors. Direct competitive pricing eliminates trading company margins, offering our customers savings of 25-40% versus European-sourced material. Our minimum order quantity is 5 kg for initial evaluation, with commercial orders typically starting from 25 kg. We offer quarterly pricing reviews linked to raw material indices and welcome long-term supply agreements of 12-36 months with guaranteed capacity reservation. Current production capacity allows us to fulfill orders up to 2,000 kg per month, with planned expansion to 3,500 kg/month by mid-2027. Safety stock of 3 months is maintained for contracted customers.

Product Specifications