Source White Ofloxacin Powder for Human, Animal, and Pharmaceutical Uses

Strategic Sourcing Guide for White Ofloxacin Powder

Procuring white ofloxacin powder requires a disciplined approach that balances technical precision with rigorous compliance verification. As a critical antibacterial agent, this chemical reagent is subject to stringent quality standards and regulatory oversight. Buyers entering this market must navigate a complex landscape of specifications, certifications, and supply chain logistics. The following guide outlines the essential parameters for sourcing this material safely and effectively, relying strictly on observed product attributes and established industry practices.

Technical Specifications and Physical Characteristics

The primary identifier for this material is its physical appearance and chemical form. Sourcing data consistently indicates that the product is supplied as a white powder. This visual characteristic is a fundamental quality marker; any deviation from a pure white color may indicate impurities or degradation. The material is described as odorless, which is a critical attribute for pharmaceutical-grade substances, ensuring that the raw material does not introduce unwanted sensory profiles into final formulations.

Chemically, the substance is identified by the CAS number 82419-36-1. This unique identifier is non-negotiable for verification purposes. When evaluating potential suppliers, buyers must ensure the documentation explicitly references this CAS number to avoid confusion with related compounds or analogues. The state of the material is solid, and it is classified as non-volatile. This physical property has significant implications for storage and handling; the material does not require specialized containment for vapor control but does demand protection from environmental factors that could alter its chemical stability.

Purity is a central technical requirement. Observed listings frequently cite a purity level greater than 99%. While this figure represents a high standard, it is an observation of specific product listings rather than a universal guarantee for all suppliers. Buyers must treat this as a baseline expectation and verify the actual assay results through independent testing. The material is often categorized under the "Medicine Grade" and "Pharmaceutical Grade" standards, indicating its intended use in therapeutic applications. Additionally, the product is sometimes listed with specific model identifiers such as "LM-Ofloxacin," "HB-Ofloxacin," or "CPF," which may denote specific manufacturing batches or proprietary formulations.

Regulatory Compliance and Certification Verification

Navigating the regulatory landscape is perhaps the most critical aspect of sourcing this chemical. The market for ofloxacin powder is heavily regulated due to its classification as an antibiotic and antimicrobial agent. Buyers must verify that suppliers possess valid certifications that align with the destination market's requirements. Observed product data highlights a range of certifications including BP (British Pharmacopoeia), USP (United States Pharmacopeia), ISO HSE, GMP (Good Manufacturing Practice), and FDA approval.

The presence of a GMP certification is particularly significant, as it indicates that the manufacturing facility adheres to strict quality control procedures during production. Similarly, certifications like BP and USP are essential for products intended for markets that recognize these pharmacopoeial standards. It is important to note that while some listings mention FDA certification, buyers must verify the specific scope of this approval, as it may relate to the facility rather than the specific batch of powder.

Documentation is the tangible proof of compliance. Suppliers are expected to provide a Certificate of Analysis (COA) and a Material Safety Data Sheet (MSDS). The COA serves as the primary evidence of the product's identity, strength, quality, and purity. It should detail the results of the test methods used, such as High-Performance Liquid Chromatography (HPLC), which is the standard analytical method cited for this product. The MSDS provides essential safety information regarding handling, storage, and emergency measures. Without these documents, a shipment cannot be considered compliant for pharmaceutical or veterinary use.

Cost Drivers and Pricing Dynamics

The pricing of white ofloxacin powder is influenced by several variables, including purity levels, packaging formats, and the scale of the order. The observed market data indicates a wide price range, with listings spanning from $0.50 to $1205 USD. This broad spectrum reflects the difference between small-scale samples, bulk industrial quantities, and specialized packaging configurations.

The Minimum Order Quantity (MOQ) is a significant factor in determining the unit cost. Data shows an MOQ range from 1 kg to 5000 units, with 1 kg being a common entry point for testing or small-batch production. As the order volume increases, the unit price typically decreases, but the total financial commitment rises. Buyers should be aware that the "1kg/Bag" and "25kg/Drum" packaging options are standard, and the choice of packaging can impact the final cost due to material and handling expenses.

Customization is a key cost driver. The product is listed as "Customized" and "Customization Available," suggesting that suppliers can adjust parameters such as particle size, specific purity thresholds, or packaging requirements. These customizations invariably add to the production cost and may extend the lead time. Furthermore, the grade of the product plays a role; "Medicine Grade" and "Pharmaceutical Grade" materials command a premium over lower-grade industrial chemicals due to the rigorous testing and quality assurance processes required.

Typical Applications and Usage Scenarios

White ofloxacin powder serves a dual role in the pharmaceutical and veterinary sectors. Its primary function is identified as "Antibacterial Drugs" and "Antibiotic and Antimicrobial Agents." This classification confirms its utility in treating bacterial infections. The product is suitable for a broad demographic, including adults, children, and the elderly, which underscores its versatility in human medicine formulations.

In the veterinary sector, the material is specifically noted for use in pigs. This application highlights the importance of sourcing from suppliers who understand veterinary pharmacopoeia standards. The availability of specific concentrations, such as 5%, 10%, 20%, and 30%, suggests that the powder is often used as an active ingredient in compounded preparations or premixes for animal feed and water. The "10% & 20%" specifications indicate that the powder is frequently processed into these ratios for specific therapeutic needs.

The material is also classified as a "Chemical Reagent," which opens up applications in laboratory research and quality control testing. In this context, the high purity (>99%) and specific CAS number are vital for ensuring the accuracy of experimental results. The non-volatile nature of the solid powder makes it suitable for various chemical synthesis processes where stability is required.

Supplier Evaluation and Selection Criteria

Selecting a reliable supplier requires a multi-faceted evaluation strategy. Buyers should prioritize suppliers who demonstrate transparency in their product attributes and certifications. The origin of the product is a relevant factor; observed data points to China, and more specifically, Xi'an, as a production hub. While this location is a known center for pharmaceutical manufacturing, buyers must verify the specific facility's reputation and compliance history.

The ability to provide samples is a critical indicator of supplier confidence. The availability of samples allows buyers to conduct independent verification of the product's physical properties, such as color, odor, and solubility, before committing to a large order. A supplier that readily provides samples and supports them with a COA is generally more trustworthy.

Payment terms and shipping logistics are also part of the evaluation. Common payment methods include TT (Telegraphic Transfer), PayPal, and Western Union. While these methods offer flexibility, buyers should assess the security of the transaction and the reputation of the payment gateway. Shipping options like FedEx, UPS, and specialized lines indicate a supplier's capability to handle international logistics. However, the specific lead times and shipping costs should be clarified before finalizing an agreement, as these can vary significantly based on the destination and the urgency of the order.

Quality Control and Long-Term Procurement Considerations

Maintaining product integrity throughout the supply chain is essential for white ofloxacin powder. The recommended storage condition is a "Cool Dry Area." This requirement is non-negotiable; exposure to moisture or high temperatures can degrade the chemical structure of the antibiotic, rendering it ineffective or unsafe. Buyers must ensure that their own storage facilities meet these criteria or that the supplier provides temperature-controlled logistics.

The test method, specifically HPLC, is the standard for verifying the quality of the powder. Buyers should insist on HPLC test results included in the COA for every batch. This analytical technique provides a precise measurement of the active ingredient's concentration and the presence of any impurities. Relying on visual inspection alone is insufficient; the "White Powder" appearance must be corroborated by quantitative data.

For long-term procurement, consistency is key. The "Customized" nature of the product means that specifications may vary between batches if not strictly controlled. Buyers should establish a clear specification sheet that defines acceptable ranges for purity, particle size, and packaging. Regular audits of the supplier's quality management system, particularly their adherence to GMP standards, are necessary to ensure ongoing compliance. Additionally, the "Single Gross Weight" of 1.5kg and package dimensions of 40x20x40 cm provide logistical data that must be accounted for in inventory planning and freight calculations.

Conclusion

Sourcing white ofloxacin powder is a complex process that demands attention to detail in technical specifications, regulatory compliance, and supply chain management. The product's identity is anchored by its CAS number 82419-36-1 and its status as a white, odorless, non-volatile powder with high purity. Compliance with standards such as BP, USP, and GMP is mandatory, and verification through COA and MSDS documentation is essential.

Buyers must navigate a market with diverse pricing and MOQ structures, ranging from small samples to bulk drums. The applications span human medicine and veterinary care, requiring a supplier capable of meeting the specific needs of both sectors. By rigorously evaluating suppliers based on their certification status, sample availability, and quality control protocols, buyers can secure a reliable supply of this critical pharmaceutical ingredient. Ultimately, the success of the procurement process depends on the buyer's ability to verify every claim against the provided data and to maintain strict standards for storage and handling.