Clindamycin HCl CAS 21462-39-5 — China API Manufacturer | ChP/USP/EP R&D to Production

Product Overview & China Manufacturing Landscape

Clindamycin hydrochloride is a lincosamide antibiotic effective against gram-positive aerobes and a wide range of anaerobic bacteria, used extensively in treating skin and soft tissue infections, bone and joint infections, pelvic inflammatory disease, and as a prophylactic antibiotic. With CAS number 21462-39-5 and molecular formula C₁₈H₃₃ClN₂O₅S·HCl, clindamycin HCl is included on the WHO Model List of Essential Medicines. China is a major global producer, with approximately 12 NMPA-registered manufacturers and combined annual production capacity exceeding 1,500 metric tons. The manufacturing base is concentrated in Shandong and Hebei provinces, where our facility benefits from established lincosamide antibiotic expertise dating back over two decades. Our production uses China’s dominant position in lincomycin fermentation — the biological starting material for semi-synthetic clindamycin production.

Our Manufacturing Process & Facility Standards

Our clindamycin HCl production is a semi-synthetic process beginning with pharmaceutical-grade lincomycin produced via Streptomyces lincolnensis fermentation at our affiliated bioprocessing facility. The key chemical transformation involves chlorination of the 7-hydroxyl group with inversion of stereochemistry, converting lincomycin to clindamycin. This reaction is conducted using thionyl chloride under precisely controlled conditions to achieve >98% conversion with minimal side product formation. Subsequent purification by selective crystallization and hydrochloride salt formation yields the finished API. Manufacturing takes place in our 18,000 square meter production facility featuring dedicated antibiotic production suites, ISO 14644-1 Class 7 cleanroom environments, and fully automated reactor systems with DCS process control. In-process quality controls include HPLC monitoring of lincomycin-to-clindamycin conversion ratio, stereoselective analysis confirming 7(S)-chloro-7-deoxy configuration, residual lincomycin content tracking, and crystallization endpoint determination. Batch size is 800-1,200 kg with assay RSD below 0.7% across 150+ consecutive commercial batches.

Quality Standards & Multi-Pharmacopeial Compliance

Our clindamycin HCl API meets ChP 2020, USP-NF, EP 11.0, and BP monograph requirements simultaneously. Typical assay values are 96.0-100.5% on an anhydrous basis (per USP potency method). Key quality parameters under strict control include: clindamycin B content (per pharmacopeial limit), lincomycin residual content (≤3.0% per EP), related substances by HPLC (total ≤5.0% including clindamycin B), specific optical rotation (per pharmacopeial range), pH of solution (3.0-5.5 for 10% w/v), water content (≤6.0% by Karl Fischer), heavy metals (≤20 ppm), sulfated ash (≤0.5%), and residual solvents per ICH Q3C. For injectable-grade material, additional testing includes bacterial endotoxin (≤0.5 EU/mg), sterility testing, and particulate matter evaluation. Our QC laboratory validates every batch against the customer-specified pharmacopeial standard. Complete COA documentation with detailed impurity profiles and microbiological potency data accompanies each shipment.

Regulatory Documentation & Registration Support

Our clindamycin HCl regulatory portfolio includes: NMPA drug registration certificate, US FDA Type II DMF with active annual updates, European CEP from EDQM, WHO prequalification certificate, quality certificates from Chinese provincial authority and international audit bodies, and FDA establishment registration. We have filed additional DMFs in Brazil, Mexico, South Korea, and several ASEAN and African countries. Our manufacturing site has been inspected by the US FDA, EU member state regulatory inspectorates, WHO prequalification inspection team, and ANVISA with no critical findings. Our regulatory team provides complete support for customer registrations including CTD Module 3.2.S documentation, analytical method transfer protocols, reference standard provision, and technical response preparation for regulatory authority queries. We actively support WHO prequalification programs for generic clindamycin finished products by providing prequalification-ready API dossiers to FPP applicants.

Packaging, Storage & Global Logistics

Clindamycin HCl API is packaged in double-layer polyethylene bags within fiber drums. Standard packaging sizes include 5 kg, 10 kg, and 25 kg per drum. Storage requires controlled room temperature (below 30°C) in a dry environment protected from light, with a validated shelf life of 36 months. Our logistics team coordinates shipments to customers across 50+ countries. Transit options include sea freight (20-35 days to major global ports), China-Europe rail (14-18 days), and air freight (3-7 days). For high-volume orders, we arrange FCL shipments with optimized container utilization. For time-sensitive or smaller orders, we utilize LCL consolidation through our logistics partners’ hub networks. All export documentation — including WHO Certificate of Pharmaceutical Product (CPP), certificates of origin, free sale certificates, and MSDS — is prepared by our dedicated export documentation team with typical document preparation time of 2-3 business days.

Competitive Pricing & Supply Reliability

Our vertically integrated production from lincomycin fermentation through finished clindamycin HCl API provides unmatched cost competitiveness. With control over the biological starting material supply, we eliminate raw material price volatility that affects non-integrated manufacturers. Competitive pricing typically delivers 35-50% savings versus European and Indian sources. MOQ is 50 kg for new customer qualification, with standard commercial orders from 200 kg. We offer annual fixed-price contracts, semi-annual pricing reviews for non-contracted customers, and volume rebate programs for annual purchases exceeding 5 metric tons. Our monthly production capacity of 30+ metric tons ensures reliable allocation for customers of all sizes. Strategic inventory of both lincomycin starting material (3 months) and finished clindamycin HCl API (safety stock of 20 metric tons) provides multi-layered supply security.

Product Specifications