Source adult losartan potassium powder for pharmaceuticals, research, and manufacturing

Strategic Sourcing Guide for Adult Losartan Potassium Powder

Understanding the Core Product Profile and Technical Specifications

When initiating a procurement strategy for adult losartan potassium powder, the buyer must first establish a precise technical baseline. The product is fundamentally identified as a white to off-white crystalline powder, a physical state that is critical for downstream pharmaceutical formulation and manufacturing processes. The molecular formula for the primary variant is C22H22ClKN6O, with a molecular weight of 461.007 g/mol. It is essential to distinguish this from related compounds, such as Losartan (free acid), which possesses a different molecular formula (C22H23ClN6O) and a lower molecular weight of 422.917 g/mol. The distinction is not merely semantic; it dictates the stoichiometry required for drug synthesis and the final dosage form efficacy.

The physical properties of the powder are well-documented in available specifications. The substance exhibits a density of approximately 0.986 g/mL at 25°C, a value that influences bulk handling and packaging logistics. The melting point is a critical thermal parameter, typically observed in the range of 183.5°C to 184°C. This thermal stability profile is vital for determining the appropriate processing temperatures during granulation or tablet compression. Furthermore, the chemical stability is supported by a partition coefficient (LogP) of 3.89590, indicating moderate lipophilicity, which is relevant for understanding the drug's absorption characteristics. The polar surface area (PSA) is recorded at 89.61 Ų, a factor that impacts membrane permeability.

For procurement purposes, the CAS number serves as the definitive identifier. The potassium salt form is associated with CAS 124750-99-8, whereas the free acid form is linked to CAS 114798-26-4. Confusion between these two identifiers can lead to significant supply chain errors. The product is classified under HS Code 2942000000 for international trade, and the specific product model often referenced in supply contexts is HNR-Losartan Potassium. Buyers must ensure that the supplier's documentation aligns with these specific identifiers to guarantee the receipt of the correct chemical entity.

Compliance Framework and Certification Verification

In the pharmaceutical ingredient sector, compliance is not optional; it is the foundation of market access and product safety. The supply chain for adult losartan potassium powder must be vetted against rigorous certification standards. Available data indicates that suppliers in this category often hold certifications including BP (British Pharmacopoeia), USP (United States Pharmacopeia), ISO HSE, and GMP (Good Manufacturing Practice). These certifications are not merely labels but represent adherence to specific quality management systems and safety protocols.

The European Pharmacopoeia (EP) and other regional standards often require strict adherence to purity levels. The observed standard for this product is frequently listed as >99%. However, buyers should treat this as a target specification rather than a universal guarantee. The actual purity must be verified through the Certificate of Analysis (COA) provided for each batch. The COA is a specific document that details the test results for the particular lot being shipped. It is imperative that the buyer requests a COA that explicitly references the test method used, which is typically High-Performance Liquid Chromatography (HPLC) or HPLC UV.

The origin of the product is another critical compliance factor. The supply data points to origins in Xian or Shaanxi Xi'an, China. While this geographic information helps in mapping the supply chain, it does not inherently guarantee quality. The buyer must verify that the manufacturing facility in this region holds valid GMP certification and that the specific batch has been tested against the relevant pharmacopoeial standards. The shelf life of the product is generally cited as 2 years, but this is contingent upon proper storage conditions. Buyers must ensure that the supplier's packaging and storage protocols maintain the integrity of the powder throughout the logistics chain to prevent degradation before the expiration date.

Cost Drivers and Economic Factors in Procurement

The pricing structure for pharmaceutical-grade active pharmaceutical ingredients (APIs) like losartan potassium is influenced by a complex matrix of variables. The observed price range in the market spans from $1 to $2,735 USD. This wide variance is not indicative of product quality differences alone but reflects significant differences in order volume, packaging specifications, and supplier positioning. The Minimum Order Quantity (MOQ) is a primary driver of unit cost, with observed ranges extending from 1 unit to 1,000 units.

Smaller order quantities, often closer to the lower end of the MOQ spectrum, typically command a higher price per kilogram due to the fixed costs of production setup, quality control testing, and logistics. Conversely, larger orders allow for economies of scale, potentially lowering the unit cost. However, the total investment must be weighed against inventory holding costs and the risk of obsolescence. The product origin, specifically from the Shaanxi region, may offer competitive pricing advantages due to local manufacturing clusters, but this must be balanced against shipping costs and import duties.

Packaging is another significant cost driver. The product packing is listed as "negotiable," meaning that the cost can vary based on the buyer's specific requirements. Standard industrial packaging (e.g., 25kg drums) is generally more cost-effective than specialized, small-batch, or vacuum-sealed packaging designed for high-moisture sensitivity. Customization is available for the product, which can include tailored labeling, specific packaging formats, or blending requirements. While customization adds value, it inevitably increases the unit price and may extend the lead time. Buyers should carefully evaluate whether the benefits of customization outweigh the additional costs, particularly for large-scale production runs where standardization is preferred.

Typical Applications and Suitability Profiles

The primary application of adult losartan potassium powder is in the pharmaceutical industry, specifically for the manufacture of antihypertensive medications. As a selective angiotensin II receptor blocker (ARB), it is used to treat high blood pressure and heart failure. The product is explicitly suitable for adults, as well as the elderly, reflecting its clinical profile in managing cardiovascular conditions in these demographics. While some data mentions suitability for children, the core focus for this specific keyword remains on adult and elderly populations.

The physical form of the product as a white powder makes it ideal for various dosage forms, including tablets, capsules, and granules. The high purity (>99%) ensures that the final drug product meets the stringent efficacy and safety requirements of regulatory bodies. The melting point and density data are particularly useful for formulation scientists who need to optimize the mixing and compression parameters during tablet manufacturing. The specific application data suggests that the product is intended for commercial pharmaceutical production rather than research or laboratory-scale experiments, given the availability of large-scale packaging and certification standards.

Buyers should note that the product is not a finished drug but an intermediate ingredient. The end-user is typically a pharmaceutical manufacturer who will further process the powder into a final dosage form. Therefore, the procurement process must consider the compatibility of the API with the manufacturer's existing production lines and formulation protocols. The specific test method (HPLC) used by the supplier must align with the quality control protocols of the buyer to ensure seamless integration into the production workflow.

Supplier Evaluation and Quality Control Protocols

Selecting a reliable supplier for losartan potassium powder requires a rigorous evaluation process that goes beyond price comparison. The first step is verifying the authenticity of the supplier's certifications. Buyers should request copies of current GMP, ISO, BP, and USP certificates and verify their validity with the issuing bodies. The presence of a COA for every batch is non-negotiable. The COA must detail the results of the HPLC or HPLC UV test method, confirming that the purity meets the >99% standard and that impurities are within acceptable limits.

The origin of the product, specifically from Xian or Shaanxi Xi'an, should be cross-referenced with the supplier's facility address. Buyers should conduct a site audit or request a third-party audit report to ensure that the manufacturing practices match the claimed standards. The product model, such as HNR-Losartan Potassium, should be consistent across all documentation. Discrepancies in the molecular formula, CAS number, or melting point between the supplier's data sheet and the buyer's technical requirements are red flags that indicate potential product substitution or documentation errors.

Quality control should also extend to the logistics chain. The shelf life of 2 years is a critical parameter. Buyers must ensure that the supplier uses appropriate packaging to maintain the product's stability during transit. The density and melting point data provided in the specifications should be used as a baseline for incoming quality control testing by the buyer. Any deviation from these physical properties could indicate degradation or contamination. The "Negotiable" standard for the product specification suggests that buyers have the opportunity to define specific acceptance criteria, which should be clearly documented in the purchase agreement.

Long-Term Procurement and Supply Chain Resilience

Sourcing losartan potassium powder is a long-term commitment that requires strategic planning to ensure supply chain resilience. The availability of customization options offers flexibility, but it also introduces complexity. Buyers should establish clear communication channels with suppliers regarding any changes in specifications or packaging requirements. The lead time, while not explicitly defined in the provided data, is a critical factor that must be negotiated. Given the global nature of the pharmaceutical supply chain, delays can have significant impacts on production schedules.

The MOQ range of 1 to 1,000 units suggests that the market supports both small-scale and large-scale procurement. However, buyers should aim to negotiate MOQs that align with their production forecast to avoid excess inventory or stockouts. The price range of $1 to $2,735 indicates that volume discounts are likely available. Buyers should structure their contracts to include price adjustment mechanisms that reflect raw material market fluctuations while ensuring stability for the long term.

Furthermore, the buyer must consider the regulatory landscape of their target market. The product's origin in China requires compliance with import regulations in the destination country. This includes ensuring that the supplier's documentation meets the specific requirements of the local regulatory authority, such as the FDA in the United States or the EMA in Europe. The specific product standard (>99%) and the test method (HPLC) must be explicitly stated in the import documentation to facilitate customs clearance.

In conclusion, sourcing adult losartan potassium powder requires a meticulous approach that balances technical specifications, compliance verification, and economic factors. By focusing on the core attributes of the product, such as its molecular weight, melting point, and purity, and by rigorously evaluating supplier certifications and quality control protocols, buyers can secure a reliable supply of high-quality API. The long-term success of this procurement strategy depends on maintaining strong relationships with suppliers, ensuring clear communication, and continuously monitoring the supply chain for any potential disruptions.