The pharmaceutical industry operates under the highest standards of quality and safety, where every component, from the active pharmaceutical ingredient (API) to its precursors, undergoes rigorous scrutiny. Omeprazole Intermediate (CAS 73590-58-6) plays a crucial role in the synthesis of Omeprazole, a vital medication for gastrointestinal health. Ensuring the quality of this intermediate is not merely a procedural step; it is fundamental to the efficacy and safety of the final drug product.

At the heart of quality control for Omeprazole Intermediate are its specifications. As a white to off-white crystalline powder, its physical appearance is the first checkpoint. However, the true measure lies in its chemical purity and composition. Our commitment as a dedicated Omeprazole intermediate manufacturer is to consistently meet and exceed the CP2015 quality standard, which mandates an assay of ≥98.50% (dried substance). This high purity level is essential to prevent unwanted side reactions and the formation of harmful impurities during the subsequent synthesis of the Omeprazole API.

Key quality control parameters for Omeprazole Intermediate include:

  • Related Substances: Stringent limits are placed on individual and total impurities (e.g., individual ≤0.30%, total ≤1.00%). Minimizing these is critical for patient safety and regulatory compliance.
  • Residual Solvents: The presence and limits of residual solvents (e.g., Methanol, Acetone, Acetonitrile) are carefully monitored. These must be within acceptable pharmaceutical guidelines to avoid toxicity.
  • Loss on Drying: This parameter indicates the amount of volatile matter present, ensuring the compound is adequately dried for stability and accurate weighing.
  • Residue on Ignition: Measures inorganic impurities, ensuring they remain below specified limits.
  • Heavy Metals: Strict controls (e.g., ≤20 ppm) are in place to prevent contamination with toxic heavy metals.
  • Microbial Limits: Ensuring low levels of microbial contamination (e.g., Total aerobic bacteria ≤1000 cfu/g, E. coli absent) is vital for pharmaceutical ingredients.

When you buy Omeprazole intermediate, partnering with a supplier that implements a robust quality management system is paramount. This includes in-process controls and final product testing conducted by qualified personnel using validated analytical methods. Our manufacturing processes are designed to ensure that every batch of Omeprazole Intermediate meets these exacting standards, providing our clients with the confidence they need.

The pursuit of the best Omeprazole price should always be balanced with the assurance of quality. A reliable Omeprazole manufacturer in China understands that investing in stringent quality control measures is an investment in the integrity of the final pharmaceutical product. For companies seeking a dependable source for high-quality Omeprazole Intermediate, we offer a combination of rigorous quality assurance, competitive pricing, and a secure supply chain. Contact us to learn more about our quality commitment and to obtain a quote.