Source pharmaceutical grade temozolomide for cancer research, drug development, and clinical trials

Strategic Sourcing Guide for Pharmaceutical Grade Temozolomide

Understanding the Technical Profile and Chemical Identity

Procuring pharmaceutical-grade Temozolomide requires a rigorous understanding of its specific chemical identity to distinguish it from other compounds that may share similar trade names or appear in broad search results. The core substance is identified by the CAS number 85622-93-1, which serves as the primary verification point for authenticity. Buyers must ensure that the supplier explicitly lists this CAS number on all documentation, including the Certificate of Analysis (CoA). In contrast, some listings in the market may reference CAS 5086-74-8, which corresponds to a different chemical structure with a molecular formula of C11H13ClN2S and a molecular weight of 240.75, often associated with antiparasitic applications rather than the antitumor profile required for Temozolomide.

The physical characteristics of the product are equally critical for inventory management and formulation compatibility. The standard appearance for pharmaceutical-grade Temozolomide is a white powder or white crystalline powder. The molecular formula for the correct substance is C6H6N6O2, with a molecular weight of 194.15. When evaluating supplier data sheets, procurement teams should verify that the state is listed as solid and that the purity is consistently reported above 99%. It is important to note that while "Customized" options are frequently available, the baseline product is often supplied as a standard white powder. The molecular weight and formula must align with the antitumor classification; discrepancies here may indicate a substitution or a mislabeled product.

Compliance Standards and Certification Verification

In the pharmaceutical supply chain, certification is not merely a marketing attribute but a prerequisite for regulatory compliance. The supplied data indicates that legitimate suppliers for this category typically hold a combination of certifications including USP, BP, ISO GMP, and ISO HSE. These standards ensure that the manufacturing process adheres to Good Manufacturing Practices (GMP) and that the product meets specific pharmacopeial standards for purity and safety.

Buyers should scrutinize the specific certification claims provided by the vendor. A robust supplier profile will list USP and BP standards, which are the United States Pharmacopeia and British Pharmacopeia, respectively. Additionally, ISO GMP certification confirms adherence to quality management systems, while ISO HSE indicates compliance with Health, Safety, and Environment regulations. Some listings may also reference specific internal standards such as "99%" or "10g/bag" as a product standard, but these should be treated as internal specifications rather than external regulatory certifications. The presence of an ISO certificate alone is insufficient; the buyer must verify that the certificate covers the specific manufacturing site and the specific product line.

The following table outlines the typical certification landscape observed in verified listings:

Cost Drivers and Minimum Order Quantity Dynamics

The pricing structure for pharmaceutical-grade Temozolomide is influenced by several variables, including the form of the product, the packaging configuration, and the scale of the order. The observed market data shows a significant variance in pricing, with ranges extending from $1 to $4,300. This wide disparity is not necessarily indicative of quality differences but often reflects the unit of measure, the specific packaging type, and the quantity ordered.

A critical factor in cost calculation is the Minimum Order Quantity (MOQ). The market data reveals a spectrum of MOQs, ranging from 1 gram to 100 kilograms. For research and development purposes, suppliers may offer samples or small batches with an MOQ as low as 1g or 100g per bag. However, for commercial manufacturing or large-scale distribution, the standard MOQ often aligns with 1kg. The packaging plays a direct role in these figures; products are commonly supplied in 1kg foil bags or 25kg drums. The transition from a 1kg foil bag to a 25kg drum often impacts the unit price and the logistics costs associated with shipping.

Buyers must also consider the "Customized" nature of the product. While customization is available, it may introduce additional costs or lead times. Conversely, "Non-Customized" or standard stock items may offer more competitive pricing and faster availability. The single gross weight of the package, observed at 1.5kg for certain configurations, is a key metric for freight calculation. Procurement teams should request a detailed breakdown of costs, separating the material cost from packaging and logistics, to accurately assess the total landed cost.

Typical Applications and Target Demographics

Temozolomide is primarily recognized for its function as an antitumor agent. This specific application defines the regulatory and quality requirements for the product. The substance is indicated for use in adult populations, though some supplier listings also extend suitability to children and the elderly. This demographic flexibility must be verified against the specific regulatory approvals in the buyer's target market. The antitumor function is distinct from other applications, such as antiparasitic uses, which are associated with different chemical structures and CAS numbers.

The product is available in a solid state, specifically as a powder, which allows for various downstream processing options. The powder form is suitable for formulation into capsules, tablets, or other dosage forms depending on the manufacturer's needs. The shelf life of the product is typically documented as 2 years, which is a critical parameter for inventory planning and supply chain logistics. Buyers must ensure that the delivery schedule aligns with this shelf life to prevent product degradation before use.

Supplier Evaluation and Quality Control Protocols

Evaluating a supplier for pharmaceutical-grade Temozolomide requires a multi-faceted approach that goes beyond checking the initial product listing. The presence of a "Sample Available" attribute is a positive indicator, allowing buyers to conduct preliminary testing before committing to a larger order. The testing method for the product is frequently cited as HPLC (High-Performance Liquid Chromatography), which is the industry standard for verifying purity and identifying impurities.

When evaluating a potential supplier, procurement teams should request the following documentation:

1. Certificate of Analysis (CoA): Must confirm the CAS number 85622-93-1, purity >99%, and appearance as a white powder.
2. Test Method Details: Verification that HPLC was used for the analysis.
3. Packaging Specifications: Confirmation of the packaging type, such as vacuum-sealed foil bags, 1kg per bag, or 25kg per drum.
4. Origin Verification: The product origin is listed as China in many verified cases, but buyers should confirm the specific manufacturing location and facility details.

The brand name "Biohorlden" appears in some listings, but buyers should not rely on brand names alone. Instead, the focus should remain on the technical data and certifications. The product model numbers, such as A681, SWP M0311, or HB-Temozolomide, serve as internal identifiers and should be cross-referenced with the CoA to ensure consistency.

Long-Term Procurement Considerations and Logistics

Sourcing Temozolomide is not a one-time transaction but a long-term relationship that requires careful logistics planning. The packaging specifications, such as the 40x20x40 cm single package size, are essential for calculating shipping volume and freight costs. The transition from small foil bags to larger drums requires careful handling to maintain the integrity of the vacuum seal and prevent moisture ingress, which could compromise the stability of the powder.

Buyers should also consider the lead times associated with different order sizes. While samples may be available immediately, larger orders of 25kg drums may require production time. The "Customized" attribute suggests that suppliers can adapt packaging or labeling, but this customization process will inevitably extend the lead time. For long-term contracts, it is advisable to establish a safety stock level that accounts for the 2-year shelf life, ensuring that inventory is rotated effectively to prevent waste.

Furthermore, the "Food Grade" designation observed in some listings should be treated with caution. While it indicates a high level of purity, the primary application of Temozolomide is pharmaceutical (antitumor), not food. Buyers must ensure that the "Food Grade" claim does not conflict with the regulatory requirements for pharmaceutical use in their jurisdiction. The final decision on procurement should be based on a comprehensive review of the technical specifications, certification validity, and the supplier's ability to maintain consistent quality over time. By adhering to these rigorous evaluation criteria, buyers can secure a reliable supply of high-quality Temozolomide for their pharmaceutical operations.