Ceftriaxone Sodium Powder

Ceftriaxone Sodium Powder – Pharmaceutical Grade API for Injectable Antibiotic Formulations

Xi'an Le-Nutra Ingredients Inc. supplies pharmaceutical-grade Ceftriaxone Sodium Powder (CAS 74578-69-1) manufactured in our 60,000㎡ GMP-certified production facility. With an assay of ≥90.0% and total impurities controlled at ≤2.5%, our product meets stringent injectable formulation requirements. Backed by over 14 years of industry expertise and 3,000 tons annual production capacity, we deliver consistent quality with bacterial endotoxins ≤0.20 EU/mg and particulate matter ≥10μm at ≤3000 Pc/g. Our direct factory supply ensures competitive pricing, stable inventory availability, and 98% on-time delivery to pharmaceutical manufacturers worldwide.

Product Specifications

Why Choose Our Ceftriaxone Sodium API?

It is a third generation cephalosporin antibiotic and a key active pharmaceutical ingredient for broad range antibacterial compositions. Our manufacturing process offers solutions to the major difficulties of the pharmaceutical business through precision control and quality assurance.

Your presentation has exact physical chemical characteristics. Our product has good water solubility and stable crystalline structure and avoids common reconstitution problems in injectable preparations. The regulated particle size distribution allows for smooth sterile filtration, minimising equipment downtime and production waste.

You still have to comply with regulations in drug manufacturing. All documentation including FDA registration, ISO certifications, Certificate of Analysis (COA), Technical Data Sheet (TDS), Material Safety Data Sheet (MSDS) and Method of Analysis (MOA) is provided batch to batch. Full traceability meets your validation criteria and audit trails.

Core Clinical and Formulation Advantages

The prolonged half-life of this cephalosporin derivative provides for easier dosage regimens in the clinical situation. This pharmacokinetic advantage results in greater patient compliance and reduced health care expenses. Pharmaceutical manufacturers like this feature since it makes stability testing and shelf-life estimation easier.

This API has the capability of penetrating tissue and hence can be used for treatment of infections at numerous anatomical sites. The wide range of therapeutic applications supports a variety of formulation options from the respiratory tract to soft tissue and bone infections. Now your R&D team can target specific therapeutic regions with more freedom, without sacrificing efficacy.

Our rigorous control of bacterial endotoxins and particulates has a direct effect on the safety profile of your finished injectable goods. Controlled particulate counts minimise the danger of vascular problems, and low endotoxin levels minimise pyrogenic reactions. These quality characteristics result in better rates of regulatory approval and acceptance in the market.

Manufacturing Excellence and Supply Chain Reliability

Your supply is assured with 6 versatile production lines with an annual production capacity of 3000 tonnes, whatever the order volume. We hold a safety stock of over 30 days to protect you against raw material shortages and market changes. The inventory buffer allows for rapid response to urgent requests and seasonal demand.

Sophisticated analytical instrumentation and rigorous process controls assure uniformity from batch to batch. Every production batch is tested by multiple stages before to use, including HPLC purity analysis, residual solvent screening and microbiological investigation. Your formulation development benefits from predictable ingredient performance across batches.

Global logistics alliances offer variable delivery terms such as EXW, FOB, CFR, CIF, DAP, and DDP. We accept various payment methods such as T/T, Alibaba Trade Assurance and local payment platform. Typical packaging is 25 kg fibre drums with double layer PE inner bags, enabling the product to maintain its integrity during international transportation.

Comprehensive Technical Support for Pharmaceutical Development

Your formulations need a guide of an expert. Our skilled R&D team provides application specific technical consulting for solubility augmentation, stability optimisation and compatibility testing. If you are formulating single-dose vials or multi-dose containers, we support your formulation architectural selections.

The OEM and ODM services are not just about providing APIs. We collaborate on unique specifications, purification needs and packaging options to suit your manufacturing flow. Private labelling alternatives enable you to develop a brand reputation in competitive pharmaceutical marketplaces.

Comprehensive document packages for a smooth regulatory submission process. We give comprehensive impurity profiles, polymorphic form characterisation and stability data under varied storage circumstances. This end-to-end technical support helps to speed up your product development schedule and time-to-market.

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Storage and Handling Recommendations

Store Ceftriaxone Sodium Powder in a cool, dry place, away from direct light and moisture. Proper storage conditions maintain chemical stability and microbiological quality throughout the 24-month shelf-life. Unopened original package and storage conditions recommended to retain product integrity.

Temperature cycling and humidity exposure may affect powder flow characteristics and reconstitution behaviour. We propose the implementation of environmental monitoring in the storage areas to maintain ideal conditions. Your quality control team should check appearance and assay values before starting large scale production runs.

FAQ

Q: What are the application scenarios for this product?

A: This is a pharmaceutical grade material that is used in the creation of antibiotic medication products, the manufacture of injectable formulations and API production. It enables generic medication manufacture and research into innovative delivery systems where wide-spectrum antibacterial action is required.

Q: Why is this product suited for injectable formulations?

A: High purity ≥90.0%, regulated impurity profile of less than 2.5% and excellent water solubility provides an ideal basis for parenteral formulations. The steady physicochemical features ensure consistent reconstitution behaviour and clarity of solution in the finished injectables.

Q: What after sales service do you provide?

A: Our technical team provides expert advice in formulation development, compatibility investigations and stability optimisation. We help with technique transfer, troubleshooting during scale up and regulatory documentation preparation to assure your project success.

Q: What quality documents are there?

A: We supply FDA registration certificates, ISO certifications, batch-specific COA, comprehensive TDS, safety-focused MSDS, and validated MOA documentation. Additional testing results and regulatory support documentation are available upon request to accommodate your specific compliance needs.

Partner With a Reliable API Manufacturer

Ready to secure your Ceftriaxone Sodium Powder supply? Contact our team at enquiry@lenutra.com for technical specifications, quotations, or sample requests.