Find refined clopidogrel hydrogen sulfate for Pharma, Cosmetic, and Industrial Uses

Strategic Sourcing Guide for Refined Clopidogrel Hydrogen Sulfate

Understanding Product Specifications and Chemical Identity

The procurement of refined clopidogrel hydrogen sulfate requires a precise understanding of its chemical identity and physical state to ensure the material meets pharmaceutical manufacturing requirements. Based on the available market data, the product is identified by the CAS number 120202-66-6. It is critical to distinguish this specific salt form from other potential variants, such as those associated with CAS#135046-48-9, which may appear in broader chemical listings but represent different chemical entities. The refined clopidogrel sulfate is characterized as a solid in its physical state, typically appearing as a white to off-white powder. This visual consistency is a primary indicator of product integrity during initial visual inspection.

The purity of the material is a non-negotiable specification for pharmaceutical applications. Market observations indicate purity levels exceeding 98%, with some listings specifying grades that exceed 99%. Buyers must verify that the specific batch they are procuring aligns with the required purity threshold for their formulation. The melting point is a definitive physical constant for this compound, observed at 184°C. This thermal property serves as a critical verification point during quality control processes to confirm the identity of the substance. Furthermore, the product is available in various forms, including bulk powder and finished dosage forms such as 75mg tablets, though the core keyword specifically targets the refined chemical intermediate. The standard packaging for the raw powder is typically 25kg per drum, while finished goods may be packaged in boxes or bottles. Customization of packaging is available, allowing suppliers to meet specific logistical or regulatory requirements of the buyer.

Compliance Framework and Certification Verification

In the pharmaceutical supply chain, compliance is the cornerstone of risk management. The sourcing of refined clopidogrel hydrogen sulfate must be anchored in rigorous certification verification. The product data indicates that suppliers should possess certifications including BP (British Pharmacopoeia), USP (United States Pharmacopeia), and ISO GMP (Good Manufacturing Practice). Additionally, certificates such as ISO/GMP, DMF (Drug Master File), and Cep (Certificate of Suitability) are noted as available documentation. These documents are not merely administrative; they are legal attestations that the manufacturing process adheres to international quality standards.

Buyers must also be aware of safety and environmental certifications. Some listings reference ISO HSE (Health, Safety, and Environment) alongside GMP, indicating a supplier's commitment to operational safety. When evaluating a potential supplier, the procurement team should request copies of these certificates and verify their validity dates and scope. It is essential to note that while "Industrial Grade" and "Pharma/Cosmetic" grades are both observed in the broader chemical market, the specific application of clopidogrel sulfate as a pharmaceutical ingredient necessitates the Pharma/Cosmetic grade. Confusion between these grades can lead to regulatory non-compliance. The product origin is listed as China, which is a major manufacturing hub for active pharmaceutical ingredients (APIs), but the origin does not dictate quality; rather, the specific facility's certification status does.

Cost Drivers and Pricing Dynamics

The pricing structure for refined clopidogrel hydrogen sulfate is influenced by several variables, including purity levels, certification status, and order volume. The observed market price range is broad, spanning from $0.30 to $1,200.00 per unit. This wide variance is not indicative of a single product but rather reflects the difference between raw material pricing, finished dosage forms, and the scale of the transaction. For the refined chemical powder, the price is likely driven by the cost of raw materials, the complexity of the chemical synthesis process, and the regulatory overhead associated with maintaining GMP and DMF status.

The Minimum Order Quantity (MOQ) is another significant cost driver. The market data shows an MOQ range from 1 unit up to 100,000 units, with a specific observation of 1 Kg as a standard entry point for bulk orders. Smaller quantities, such as 10g samples, are available for testing and validation purposes. However, purchasing in smaller increments typically incurs a higher unit cost due to the fixed costs of packaging, documentation, and logistics. Conversely, larger orders may benefit from economies of scale but require significant capital outlay and storage capacity. Buyers should also consider the "Customization" factor; while customization is available, requests for non-standard packaging or specific purity levels above the baseline may introduce additional costs. The shelf life of the product, noted as 2 years, also impacts cost, as inventory management strategies must align with this expiration window to prevent waste.

Typical Applications and Suitability Profiles

Refined clopidogrel hydrogen sulfate is primarily utilized in the pharmaceutical industry for the manufacture of medications targeting cardiovascular conditions. The product is suitable for adult populations, with some data suggesting suitability for children and the elderly as well, depending on the specific formulation and dosage. The application is strictly pharmaceutical, falling under the category of inorganic chemicals used in chemical synthesis. The manufacturing process involves chemical synthesis, a method that requires precise control over reaction conditions to ensure the final product meets the required purity and safety standards.

The product is not intended for industrial or cosmetic use in its raw form, despite the "Pharma/Cosmetic" grade label appearing in some contexts. The primary application is the production of antiplatelet agents. The standard dosage forms associated with this chemical include 75mg and 80/400mg specifications, indicating its use in tablet formulations. The "Characteristic" taste and "Odorless" nature of the substance are relevant for formulation scientists working on taste-masking technologies or ensuring patient compliance. It is crucial to distinguish this product from other chemicals listed in the same market space, such as Hydrogen Sulfide (CAS#135046-48-9), which is an inorganic gas with hazardous properties (DOT Class 2.1+2.3, UN No. 1053) and is not a pharmaceutical ingredient. The confusion between these two distinct chemical entities must be avoided to prevent catastrophic procurement errors.

Supplier Evaluation and Risk Assessment

Evaluating a supplier for refined clopidogrel hydrogen sulfate requires a multi-faceted approach that goes beyond price comparison. The first step is verifying the supplier's ability to provide the necessary documentation, including the DMF and Certificates of Analysis (CoA). The presence of a DMF is particularly important as it facilitates the regulatory filing process for the buyer's own drug applications. Buyers should also assess the supplier's production capacity and lead times. While specific lead times are not universally standardized in the provided data, the MOQ of 1 Kg suggests that suppliers are equipped to handle both small-scale R&D orders and large-scale commercial production.

Safety and handling capabilities are also critical evaluation criteria. Although clopidogrel sulfate itself is a solid powder, the broader chemical market includes hazardous gases like Hydrogen Sulfide, which require specialized handling (Cylinder Standard: DOT/ISO/GB/TUV, Valve: Cga330). A supplier capable of handling both pharmaceutical solids and hazardous gases demonstrates a robust safety infrastructure, but buyers must ensure that the specific product being ordered is handled according to its specific safety data sheet (SDS). The "Chemical Property" of the product should be confirmed; while clopidogrel sulfate is a solid, other products in the same catalog may be classified as "Poisonous Gases" or "Inflammable Gas." Clear communication of the specific CAS number (120202-66-6) is essential to avoid receiving the wrong material.

Quality Control and Testing Protocols

Quality control (QC) is the final gatekeeper in the procurement process. Buyers must implement a rigorous testing protocol that aligns with the product's specifications. The primary QC metrics include visual inspection for the white to off-white powder appearance, verification of the melting point at 184°C, and chemical analysis for purity levels exceeding 98% or 99%. The "Grade Standard" should be confirmed as Pharma/Cosmetic, and the "Product Standard" should match the 25kg/drum specification unless a custom request is made.

Testing should also verify the absence of contaminants and the correct chemical identity. The "HS No." 28309090 is relevant for customs clearance and should be consistent across all documentation. Buyers should request a Certificate of Analysis (CoA) for every batch, which must detail the results of purity testing, melting point verification, and any other relevant physicochemical parameters. The shelf life of 2 years must be clearly marked on the packaging, and the storage conditions should be defined to maintain product stability. For finished goods, the "Box or Bottle" packaging should be inspected for integrity to prevent contamination. The "Sample" availability of 10g is a valuable resource for initial QC testing before committing to a larger order.

Long-Term Procurement and Supply Chain Stability

Long-term procurement of refined clopidogrel hydrogen sulfate requires a strategy focused on supply chain stability and regulatory continuity. The "Customization" feature offers flexibility for future needs, such as changes in packaging or dosage specifications. However, buyers should establish long-term contracts that lock in pricing and quality standards to mitigate market volatility. The "Standard" of 25kg/drum is the industry norm, but the ability to request alternative packing is a strategic advantage for buyers with specific logistics needs.

The "Product Origin" being China is a significant factor in global supply chains. While this region is a leader in API production, buyers should diversify their supplier base to mitigate risks associated with geopolitical tensions or logistical disruptions. The "Shelf Life" of 2 years allows for reasonable inventory planning, but buyers must ensure that their procurement cycles align with this timeline to avoid expiration. The "Chemical Property" and "Hazard Class" data provided for other products in the market highlight the importance of maintaining a clear separation between different chemical categories in the supply chain. A robust supplier relationship includes regular audits, continuous quality monitoring, and open communication regarding any changes in manufacturing processes or regulatory requirements. By adhering to these principles, buyers can ensure a steady supply of high-quality refined clopidogrel hydrogen sulfate for their pharmaceutical operations.

Comparative Overview of Product Attributes

To assist in the final selection process, the following table summarizes the key attributes of refined clopidogrel hydrogen sulfate based on the observed market data. This comparison helps distinguish the target product from other chemical entities that may appear in similar search results.

This comparison underscores the necessity of precise identification. The physical state, packaging, and hazard classification are the most immediate differentiators. Confusing the solid pharmaceutical powder with the hazardous gas can lead to severe safety and regulatory consequences. Buyers must ensure that their procurement documents explicitly state the CAS number and physical state to prevent such errors.