In the pharmaceutical industry, the quality of intermediates directly impacts the final drug product. For Esomeprazole Magnesium Trihydrate (CAS 217087-09-7), ensuring high purity and consistent quality is non-negotiable. Buyers looking to buy this crucial compound must understand the critical quality control parameters and what to expect from a reputable manufacturer or supplier.

Key Quality Parameters

The most important quality parameter for Esomeprazole Magnesium Trihydrate is its purity, typically specified as ≥98%. This is usually verified through analytical techniques such as High-Performance Liquid Chromatography (HPLC). Other critical parameters include:

  • Appearance: Should be a white to off-white powder. Any deviation may indicate contamination or degradation.
  • Assay: Confirms the concentration of the active compound.
  • Identification: Tests like FTIR or NMR spectroscopy confirm that the material is indeed Esomeprazole Magnesium Trihydrate.
  • Residual Solvents: Limits are set for solvents used in the manufacturing process to ensure they are below acceptable safety thresholds.
  • Heavy Metals: Strict limits are enforced to prevent contamination.
  • Water Content: Given its trihydrate form, controlling water content is important for stability.

A reliable manufacturer will provide a comprehensive Certificate of Analysis (CoA) for each batch, detailing these specifications and the actual test results. Buyers should always review the CoA carefully before accepting a shipment.

The Manufacturer's Role in Quality Assurance

A responsible manufacturer implements a robust quality management system throughout the production process. This includes:

  • Raw Material Testing: Ensuring that incoming raw materials meet stringent quality requirements.
  • In-Process Controls: Monitoring critical steps during synthesis to maintain desired reaction conditions and purity.
  • Final Product Testing: Comprehensive analysis of the finished product to confirm it meets all specifications.
  • Stability Studies: Assessing the product's shelf life and storage conditions.
  • Batch Traceability: Maintaining records to track each batch from raw materials to finished product.

When you are ready to purchase Esomeprazole Magnesium Trihydrate, inquiring about the manufacturer's quality systems and requesting samples for internal validation is highly recommended. Obtaining a competitive quote should always be accompanied by a thorough assessment of the supplier's quality commitment.

As a dedicated supplier and manufacturer of pharmaceutical intermediates in China, we prioritize quality control at every stage. We are committed to providing our clients with Esomeprazole Magnesium Trihydrate that meets the highest industry standards, ensuring the integrity of your pharmaceutical products.