Source USP Fenofibrate Powder for Pharmaceutical, Research, and Intermediates

Strategic Sourcing Guide for USP-Grade Fenofibrate Powder

Procuring high-purity pharmaceutical intermediates requires a disciplined approach that balances technical specifications with rigorous compliance verification. For buyers targeting USP-grade Fenofibrate powder, the market offers a complex landscape of suppliers, primarily originating from major chemical manufacturing hubs. The core objective is to secure a material that meets the stringent purity thresholds and regulatory frameworks required for pharmaceutical formulation while ensuring supply chain reliability. This guide synthesizes available product attributes and industry standards to provide a framework for evaluating potential suppliers without relying on unverified claims or specific vendor recommendations.

Technical Specifications and Physical Attributes

The foundation of any successful procurement process for Fenofibrate lies in understanding the precise physical and chemical characteristics of the material. Based on observed product data, the target material is consistently described as a white fine powder or white crystalline powder. The state of the product is solid, which is standard for bulk pharmaceutical intermediates intended for further processing. The molecular formula is identified as C20H21ClO4, with a molecular weight of approximately 360.83 g/mol. These fundamental chemical properties are critical for inventory management and compatibility checks during the formulation stage.

Purity is the most significant technical differentiator in this category. High-confidence data indicates that suppliers often advertise a purity level exceeding 99%, with specific assay requirements listed as 99% minimum. This aligns with the general expectations for USP-grade materials, where impurities must be strictly controlled to ensure patient safety. The appearance is uniformly reported as white, though variations in texture, such as "fine powder" versus "crystalline powder," may exist depending on the specific synthesis batch or supplier processing methods. Buyers must verify that the visual appearance matches the specification sheet provided for the specific lot, as color deviations can indicate degradation or contamination.

The chemical identity is further confirmed by the CAS number 49562-28-9. This unique identifier is essential for cross-referencing regulatory documents and ensuring that the material ordered is chemically identical to the reference standard. Some product listings also reference specific model numbers, such as HMJ-Fenofibrate or HMJ-55, which serve as internal tracking codes for the manufacturer. While these codes help in communication, the CAS number remains the definitive standard for chemical verification.

Compliance and Certification Verification

In the pharmaceutical supply chain, certification is not merely a formality but a prerequisite for market access. The observed product data highlights a robust set of certifications that buyers should expect to see validated. Common certifications include GMP (Good Manufacturing Practice), ISO standards (specifically ISO 9001), and pharmacopoeial standards such as USP (United States Pharmacopeia) and BP (British Pharmacopoeia). Additionally, some listings mention HSE (Health, Safety, and Environment) compliance, which is vital for industrial safety protocols.

Beyond standard pharmaceutical certifications, niche markets may require Halal or Kosher certifications, which are also noted in the available data. These are particularly relevant for suppliers targeting specific demographic regions or religious dietary restrictions. The presence of these certifications on a product listing should be treated as an initial indicator, but buyers must request valid, current certificates from the supplier. It is important to note that while "USP" is a keyword in the search, the actual certification status must be verified against the official USP monograph to ensure the material meets the specific impurity limits and testing criteria defined therein.

The table below summarizes the key certifications and standards observed in the market data, which serve as a checklist for buyer verification:

Cost Drivers and Pricing Dynamics

The pricing of Fenofibrate powder is influenced by a variety of factors, including purity levels, packaging requirements, and order volume. The observed market data indicates a wide price range, spanning from $0.10 to $900 per unit, though this broad range likely reflects differences in packaging sizes (from 100g to 25kg) and order quantities rather than unit price volatility alone. The Minimum Order Quantity (MOQ) also varies significantly, ranging from 1kg to 2000kg, which directly impacts the per-unit cost structure.

Buyers should understand that "Industrial" quality materials may be priced differently from those intended for direct pharmaceutical formulation. While the data lists "Industrial" as a quality attribute for some listings, the target keyword specifies "USP," which implies a higher tier of quality control and testing. Consequently, the cost of USP-grade material will generally be higher than generic industrial-grade intermediates. The packaging method also plays a role in cost; options include foil bags, cardboard drums, and plastic bags. The standard specification often cites 25kg per drum or 1kg per foil bag, with 10 bags per carton. Larger drum quantities may offer better economies of scale, but the buyer must consider storage capabilities and shelf life constraints.

Lead times are another critical cost driver. The data suggests a delivery window of 7-10 days for stocked items, which implies that availability is a key factor in pricing. Materials that are "stocked" may command a premium due to immediate availability, whereas custom synthesis orders might have longer lead times but potentially lower unit costs for large volumes. Buyers should factor in the cost of expedited shipping if the 7-10 day window is not met, as delays in pharmaceutical production can be costly.

Typical Applications and Usage Profiles

Fenofibrate powder is primarily utilized as an organic chemical material and an intermediate in the synthesis of pharmaceutical products. The molecular structure and chemical properties make it suitable for use in formulations targeting lipid metabolism disorders. The product data explicitly lists the application as "Organic Intermediates," indicating its role as a building block rather than a final consumer product. This distinction is crucial for buyers, as the material is intended for further processing by pharmaceutical manufacturers or research institutions.

The suitability of the material extends across various demographic groups, including adults, children, and the elderly, as noted in the product attributes. This broad applicability underscores the importance of high purity and consistent quality. The storage requirements are specific: the material must be kept in a dry, cool, sealed container to maintain stability. The observed shelf life is typically around 2 years, which buyers must account for in their inventory planning. Failure to adhere to these storage conditions can lead to degradation, rendering the material unsuitable for its intended pharmaceutical applications.

Supplier Evaluation and Quality Control

Evaluating a supplier for Fenofibrate powder requires a multi-faceted approach that goes beyond simple price comparison. The origin of the product is a significant factor, with the majority of observed listings indicating China as the place of origin. While this does not preclude quality, it necessitates a thorough vetting process to ensure that the manufacturing facilities adhere to international standards. Buyers should verify the supplier's track record in producing synthesis material intermediates and their ability to provide consistent batches.

Quality control is paramount, and the testing methods employed by the supplier are a key indicator of reliability. The data highlights High-Performance Liquid Chromatography (HPLC) as the primary test method, often supplemented by UV and TLC (Thin Layer Chromatography) techniques. These methods are standard for verifying purity and identifying impurities. Buyers should insist on a Certificate of Analysis (CoA) for every batch, which must include detailed results from these tests. The CoA should confirm the assay is at least 99% and that the material matches the specified CAS number and physical appearance.

Customization is another area where supplier capability is assessed. The product data indicates that customization is available, allowing buyers to request specific packaging sizes or tailored specifications. However, this flexibility must not come at the expense of quality. Suppliers offering custom services should have a robust quality management system in place to handle non-standard requests without compromising the integrity of the material.

Long-Term Procurement Considerations

Sourcing Fenofibrate powder is not a one-time transaction but part of a long-term supply chain strategy. The availability of samples is a critical step in the procurement process, allowing buyers to test the material before committing to larger orders. The data confirms that samples are available, which is a positive indicator of supplier confidence in their product. Buyers should utilize these samples to verify the physical attributes, such as the white crystalline powder appearance, and to conduct their own internal testing or third-party analysis.

Storage and handling requirements must be integrated into the buyer's logistics plan. The specification for storage in a dry, cool, sealed container is non-negotiable for maintaining the 2-year shelf life. Buyers should ensure their storage facilities meet these criteria to prevent degradation. Additionally, the packaging options, ranging from foil bags to cardboard drums, must be compatible with the buyer's storage and handling equipment.

Finally, the global nature of the market means that buyers should consider the geopolitical and logistical factors that could affect supply. The "Worldwide" market reach indicated in the data suggests that suppliers are accustomed to international shipping, but buyers should verify the reliability of their logistics partners. Establishing a long-term relationship with a supplier who can consistently meet quality standards, provide timely delivery, and offer responsive customer service is essential for the stability of pharmaceutical production. By focusing on these long-term factors, buyers can mitigate risks and ensure a steady supply of high-quality Fenofibrate powder.