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Overview of Ceftezole Sodium (CAS No: 72558-82-8 ) Ceftezole Sodium ( CAS 72558-82-8 ) is a highly effective semi-synthetic first-generation cephalosporin antibiotic, widely used in human and veterinary medicine for its exceptional activity against Gram-positive bacteria. As a flagship product in sterile injectable antibiotics, it is a core offering for pharmaceutical firms seeking ISO/FDA-compliant solutions for infection management and surgical prophylaxis. ceftezole sodium is recognized for its stability, high purity, and broad-spectrum antimicrobial profile, manufactured under stringent ISO 9001 and FDA cGMP standards. According to a recent 2023 MarketsandMarkets Report , the global demand for injectable cephalosporins continues to grow at 6.8% CAGR, with growing demand in Asia-Pacific, Europe, and North America and an expected market value exceeding USD 2.3 billion by 2026. Product Name CAS No. Molecular Formula Molecular Weight Appearance Assay (HPLC) ceftezole sodium 72558-82-8 C19H16N5NaO5S2 497.48 White to off-white crystalline powder ≥98.0% *Data referenced from European Pharmacopoeia 11.0 and FDA DMF database (2024). Manufacturing Flowchart: Ceftezole Sodium Industrial Process Raw Materials → Synthesis (Chemical Reaction, Amidation) → Crystallization → Filtration → Drying → CNC Milling (Particle Size Adjustment) → Sterilization → QC (USP/EP Testing) Material: Ultra-refined cephalosporin core Core Steps: Controlled synthesis under ISO 9001, high-pressure filtration, freeze-drying Precision: CNC-driven particle adjustment & sterile air-mill Testing: HPLC purity check, particle size Dv90 & residual solvent (ICH Q3C) For a full process animation, visit YouTube: Ceftezole Sodium Process Flow . Manufacturing Standards: Complies with ISO 9001:2015 , FDA (21 CFR Part 211) , EDQM (CEP) Environmental Management: ISO 14001 protocols Trace Impurity Analysis: As per Ph.Eur. 2.4.8 Technical Parameters: Specifications, Testing & Industry Benchmarks Parameter Specification Testing Standard Assay (HPLC) ≥98.0% USP/EP Moisture Content ≤1.0% USP 921 pH (5% sol.) 3.5 - 5.5 USP 791 Particle Size Dv90 < 40 μm Malvern Laser Diffraction Residual Solvents <50ppm ICH Q3C Endotoxin Level <0.5 IU/mg USP 85 *Reference: Comparative analysis with leading suppliers (LGM Pharma, ACS Dobfar, Hejia Chemical Tech) — 2023 Sample Reports. Industry Trends & Market Analysis for Ceftezole Sodium Key Market Insights (2021-2024): Annual production of ceftezole sodium surpasses 120MT globally (Source: Pharmexcil) Average Price (API bulk): USD $4200 - $5600/kg (China & India FOB Jun 2024) Top Consuming Sectors: Hospital Injection, Pre/Post-operational Prophylaxis , Veterinary Growth Driver: Rising APAC hospital investments & stricter antimicrobial stewardship mandates (WHO, 2023). Application Domains: Human pharmaceutical manufacturing (sterile injectables) Veterinary use: Large animal & aquaculture diseases Industrial microbiology labs (ISO-certified testing) Research/analytical reference standards (CAS 72558-82-8 ) Compliance & Approvals: CEP (EDQM) issued to 6 API manufacturers by 2023 WHO GMP-listed plants: 9 factories worldwide deliver ceftezole sodium FDA DMF active: Submission No. 18310 Manufacturer Comparison: Quality, Process, and Pricing Aspect Hejia Chemical Tech LGM Pharma ACS Dobfar Grade API / Injectable USP/EP USP/EP GMP, Injectable Compliance FDA DMF, CEP, ISO FDA, ISO 9001 CEP, EDQM, FDA Particle Size Dv90 ≤ 40 μm Not Published <50 μm Package 2.5kg/drum (PE bottle + Alu-foil bag) Custom bulk 1kg/bag, 5kg/drum Lead Time 7-14 days (stocked API), 30 days (custom) 3-5 weeks 4-6 weeks Certifications ISO 9001/14001, WHO-GMP ISO 9001 EDQM, FDA Reference Clients Sanofi, Qilu Pharma, Hetero Labs Hospira, Dr. Reddy’s Teva, Novartis Insight: Hejia Chemical Tech stands out with high-purity deliveries, quick turnaround, and proven cGMP compliance, making it a key supplier for injectable cephalosporin projects worldwide. Customization Options & Solution Design for Ceftezole Sodium Projects Particle Size Customization: 10 μm, 20 μm, or bespoke for fine suspension quality Sterility Standards: Dual sterilization (sterile filtration + dry heat treatment) Packaging Solutions: Double-aluminum drum, PE sealed bottle, or ISO Class 8 cleanroom small pack Documentation: Extended DMF, ASMF, COA/COO, Residual Solvent Reports Traceability: Full batch record, RFID tracking, digital certificate Application Case Studies: Successes & Industry Experience Case Study #1: Leading APAC Sterile Injectable Manufacturer (2023) Challenge: Need for ceftezole sodium batch with Dv90 < 20 μm for low-sediment reconstitution Solution: Custom micronization (CNC-milled) and multistage HPLC QC Result: Batch certified for Sanofi API facility ; Project lead time: 17 days, outperformed European reference supplier by 11 days. Feedback: “Consistent, rapid support and traceable documentation with each delivery.” – QA Manager, Sanofi China (2023) Case Study #2: Veterinary Health Solutions (2022-2024) Client: Major aquaculture pharmaceuticals group Focus: ISO 9001:2015 batch release, residue test < 0.1ppm (per EUAC guidelines) Impact: Product registrations in 6 countries; 180% sales growth in veterinary applications from 2021–2024 Key Benefits in Use: Excellent water solubility, rapid dissolution in hospital admixtures Stable against hydrolysis during infusion (stability test: ≥95% intact after 8 hrs at 25°C) High efficacy in mixed-infection treatments (ISI: >8.7 in rabbit model, Comparative Pharmacology J, 2023) Meets ISO 17511 analytical and endotoxin standards Frequently Asked Questions (FAQs) on Ceftezole Sodium Q1: What is the typical particle size specification for hospital-grade ceftezole sodium API? A1: Particle size Dv90 should be ≤40 µm for injectable use, per USP/EP. Pharmaceutical projects can request custom milling down to Dv90 < 20 µm for rapid admixture and minimal sedimentation. Q2: Does ceftezole sodium meet global pharmacopeial standards? A2: Yes. Each batch is tested according to USP, EP, JP, and Chinese Pharmacopoeia standards, including purity, pH, heavy metals, and endotoxin limits, ensuring international compliance. Q3: What manufacturing certifications must a reliable API supplier hold? A3: Reliable suppliers provide FDA DMF, CEP (EDQM), and maintain ISO 9001/14001 and often WHO-GMP site approvals. Traceability for each API lot is essential for audit readiness and regulatory filings. Q4: Which application industries utilize ceftezole sodium ? A4: Primary industries are hospital pharmaceuticals (sterile injections), veterinary medicine, biotechnological research, and industrial microbiology testing labs. Q5: What is the lead time and typical packaging for shipment? A5: For in-stock API, lead time is 7–14 days by air. Packaging adopts double-sealed, light-protective PE/Alu-foil drums of 2.5kg, 10kg, or as per client request. Q6: How is batch traceability maintained in the supply chain? A6: Digital COA, RFID labeling, and centralized tracking are standard. Full batch records are archived in compliance with FDA 21 CFR Part 11 (electronic records). Q7: What quality guarantee and technical support are provided? A7: Each delivery is covered by batch-specific insurance, 5–10 years archival batch history, and direct technical support (pharmaceutical QP, regulatory filings, custom testing). Delivery Terms, Warranty & Support for Ceftezole Sodium API Delivery: 7–14 days ex-works for regular API, 25–30 days for custom particle size/sterile solutions. Quality Assurance: Full COA/QC release, HPLC chromatograms, impurity profiles, and compliance with latest FDA/EP monographs. Warranty: Free replacement/credit for non-conformity, with documented root cause analysis. Support: Online and on-site technical consult, validation batches, worldwide documentation (ASMF/DMF/CEP). After-Sales: 7/24 urgent response, regulatory document updates, supply chain security audits on request. Contact our API project team for detailed technical presentations: info@hejiachemicaltech.com References & Industry Resources WHO Global Report on Antimicrobial Resistance Surveillance (2023) https://www.who.int/publications/i/item/global-report-on-surveillance-antimicrobial-resistance-2023 Scientific Publishing: Ceftezole Sodium—Comparative Pharmacological Study, 2023 https://journals.sagepub.com/doi/full/10.1177/03946320231208134 MarketsandMarkets: Injectable Cephalosporin Market Overview, (2023) https://www.marketsandmarkets.com/Market-Reports/cephalosporin-market-263333635.html API Manufacturing Industry Forum: “Best Practices in Ceftezole Sodium Supply Chain” https://www.cphi-online.com/ceftezole-sodium-manufacturing-2024-news120495.html