Source solid dasatinib powder for Pharmaceutical, Research, and Manufacturing

Strategic Sourcing Guide for Solid Dasatinib Powder

Procuring solid dasatinib powder requires a rigorous approach that balances precise technical verification with robust supply chain compliance. As a critical pharmaceutical intermediate, this active pharmaceutical ingredient (API) demands scrutiny regarding its chemical identity, physical state, and regulatory standing. Buyers must navigate a landscape where product attributes such as purity, crystalline structure, and packaging standards vary significantly between suppliers. This guide outlines the essential factors for sourcing solid dasatinib powder, focusing on the specific data points available in the current market while emphasizing the need for independent verification of all claims.

Technical Specifications and Chemical Identity

The foundation of any successful procurement of solid dasatinib powder lies in the accurate identification of its chemical and physical properties. The core substance is identified by the CAS number 302962-49-8, which corresponds to the anhydrous form of the drug. In the market, this material is frequently observed as a white powder, a physical state that is critical for downstream formulation processes. The molecular formula for the standard anhydrous form is C22H26ClN7O2S, with a molecular weight of approximately 488.007 g/mol. These specific identifiers are non-negotiable for ensuring that the material received matches the intended pharmaceutical application.

However, sourcing strategies must also account for the monohydrate variant, which presents distinct physical characteristics. The monohydrate form is identified by the CAS number 863127-77-9 and possesses the molecular formula C22H28ClN7O3S, resulting in a higher molecular weight of roughly 506.02 g/mol. Physically, this variant often appears as a white to off-white crystalline powder, distinguishing it from the finer texture of the anhydrous powder. The melting point for the standard form is observed in the range of 275-286°C, a thermal property that serves as a key verification metric during quality control. Buyers must explicitly specify whether they require the anhydrous or monohydrate form, as the water content in the monohydrate affects stoichiometry in final drug manufacturing.

Physical parameters such as density and refractive index further aid in verification. The density is typically recorded around 1.408 g/cm³, while the refractive index is approximately 1.688. Additionally, the partition coefficient (LogP) is a critical factor for bioavailability studies, with values observed near 3.46 for the anhydrous form and 3.40 for the monohydrate. The polar surface area (PSA) also varies, with values around 134.75 Ų for the anhydrous and 143.98 Ų for the monohydrate. These numerical data points should be cross-referenced against the Certificate of Analysis (COA) provided by the supplier to ensure the material meets the required physicochemical profile.

Regulatory Compliance and Certification Standards

In the pharmaceutical sector, the validity of a supplier's certifications is as important as the chemical purity of the product. The market data indicates that reputable suppliers for solid dasatinib powder often hold certifications such as BP (British Pharmacopoeia), USP (United States Pharmacopeia), ISO GMP, and HSE (Health, Safety, and Environment) standards. These certifications are not merely marketing terms; they represent adherence to strict manufacturing and quality management systems. For instance, the presence of GMP certification implies that the production facility follows Good Manufacturing Practice guidelines, which is essential for ensuring batch-to-batch consistency and patient safety.

When evaluating a supplier, buyers should verify that the specific batch of dasatinib powder is manufactured under these certified conditions. The data shows that some listings specify "Pharmaceutical Grade" or "Healethcare Products" as the material grade, which aligns with the requirement for high-purity APIs. It is crucial to note that while a supplier may claim these certifications, the buyer must request current, valid documentation. The absence of a specific certification in a product listing does not necessarily disqualify a supplier, but the presence of these standards significantly reduces regulatory risk. Furthermore, the storage requirements for the powder are often specified as a "Dry and Cool Place," a condition that must be maintained throughout the supply chain to preserve the integrity of the solid powder and prevent degradation.

Cost Drivers and Pricing Dynamics

The pricing of solid dasatinib powder is influenced by a complex interplay of factors, including purity levels, packaging requirements, and order volume. Observed market data suggests a wide price range, with values potentially spanning from $0.50 to $500 per unit, though the specific unit of measure (e.g., per gram, per kilogram) is often determined by the MOQ and packaging configuration. The Minimum Order Quantity (MOQ) is a significant cost driver, with observed ranges starting as low as 1 kg and extending up to 100 kg or more. Suppliers offering an MOQ of 1 kg may command a higher unit price compared to those requiring bulk purchases of 25 kg drums.

Packaging also plays a pivotal role in cost determination. The standard packaging observed includes bottles and cartons for smaller quantities, while larger orders often utilize foil bags or 25 kg drums. The choice between a "Negotiable" packing arrangement and a fixed standard like "1kg/bag" can impact the final landed cost. Additionally, the availability of customization services, such as OEM labeling and custom packing bottles, adds a layer of cost that buyers must factor into their budget. While the base price of the chemical is driven by raw material costs and synthesis complexity, the value-added services of customization and specific packaging solutions can significantly alter the total procurement cost. Buyers should seek detailed quotes that break down the cost of the material, packaging, and any customization fees to ensure transparency.

Typical Applications and Suitability Profiles

Solid dasatinib powder is primarily utilized in the pharmaceutical industry for the development of drug formulations. Its application is strictly defined by its role as an active pharmaceutical ingredient (API). The target demographic for products containing this substance includes adults, the elderly, and in some specific formulations, children. This broad suitability profile necessitates that the powder meets stringent purity and safety standards suitable for diverse patient populations. The high purity levels, often cited as greater than 98% or 99%, are essential to minimize the presence of impurities that could pose risks to these vulnerable groups.

The application of dasatinib powder extends beyond simple formulation; it is integral to the development of treatments for specific medical conditions. The solid state of the powder allows for versatile processing into various dosage forms, including tablets and capsules. The chemical stability, indicated by a shelf life of approximately 2 years when stored correctly, makes it a viable candidate for long-term supply chains. However, the specific application dictates the required purity and testing methods. For instance, formulations intended for pediatric use may require more rigorous impurity profiling than those for adult use. Buyers must align their procurement specifications with the intended therapeutic application to ensure regulatory compliance and clinical efficacy.

Supplier Evaluation and Quality Control Protocols

Evaluating a supplier for solid dasatinib powder requires a multi-faceted approach that goes beyond checking a product listing. The origin of the product is a critical factor, with many suppliers based in China, specifically in regions like Xian. While the location itself is not a quality indicator, it highlights the need for buyers to understand the logistics and regulatory environment of the exporting region. The testing method employed by the supplier is another vital evaluation criterion. High-performance liquid chromatography (HPLC) is the standard method cited for verifying the purity and identity of the powder. Buyers should insist on HPLC test results as part of the COA to confirm that the observed purity levels are accurate.

Quality control protocols must be transparent and rigorous. The supplier should provide a COA that details the specific test results for the batch in question. This document should confirm the appearance, melting point, and chemical composition. The presence of a "Specific" attribute in the product data, often referring to the COA, underscores the importance of this documentation. Furthermore, the supplier's ability to offer customization, such as tailored labeling and packing, indicates a level of flexibility and customer service that is valuable for B2B procurement. Buyers should also verify the supplier's capacity to handle the required volume, as the MOQ can range from 1 kg to 100 kg. A supplier that can accommodate both small and large orders with consistent quality is preferable for long-term partnerships.

Long-Term Procurement and Supply Chain Stability

Sourcing solid dasatinib powder is not a one-time transaction but a strategic relationship that requires long-term planning. The shelf life of the product, typically 2 years, necessitates careful inventory management to prevent waste and ensure product efficacy. Buyers must establish a procurement rhythm that aligns with their production schedules while accounting for the lead times associated with international shipping. The origin of the product, often China, implies that logistics planning must include customs clearance and potential transit delays.

To mitigate risks, buyers should prioritize suppliers who offer consistent quality and reliable delivery. The ability to customize packaging and labeling allows for brand alignment and regulatory compliance in different markets. Additionally, the availability of the product in various grades, from pharmaceutical grade to specialized healthcare products, provides flexibility for different market needs. Buyers should maintain open communication with suppliers regarding changes in regulations or standards, such as updates to BP or USP monographs. By fostering a collaborative relationship with suppliers who demonstrate a commitment to quality and compliance, buyers can ensure a stable supply of solid dasatinib powder for their pharmaceutical operations.

Comparative Analysis of Product Variants

To assist in decision-making, the following table summarizes the key differences between the anhydrous and monohydrate forms of dasatinib powder based on the observed market data. This comparison highlights the critical distinctions that buyers must consider when placing an order.

This comparison underscores the necessity of precise specification. While both forms serve the same therapeutic purpose, their physical and chemical differences require distinct handling and formulation strategies. Buyers must ensure that their purchase orders explicitly state the required variant to avoid receiving the wrong material, which could lead to significant production delays and financial losses. By adhering to these detailed specifications and maintaining a rigorous evaluation process, buyers can successfully navigate the complex market for solid dasatinib powder.