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
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Synthesis (Chemical Reaction, Amidation)
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Crystallization
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Filtration
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Drying
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CNC Milling (Particle Size Adjustment)
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Sterilization
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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)
- 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)
Case Study #2: Veterinary Health Solutions (2022-2024)
- 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
- 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
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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
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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
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