In the highly regulated pharmaceutical sector, the integrity of drug substances and products is non-negotiable. A cornerstone of maintaining this integrity is the meticulous use of reference standards. These are highly purified substances that serve as benchmarks for identification, purity, and quantitative analysis of drug components, including impurities. For companies manufacturing drugs like Celecoxib, obtaining critical impurity standards, such as Celecoxib Impurity B (CAS 331943-04-5), is fundamental to robust quality assurance (QA) and quality control (QC) processes.

Celecoxib Impurity B, chemically known as N-De(4-sulfonaMidophenyl)-N'-(4-sulfonaMidophenyl) Celecoxib, is a structurally related compound to Celecoxib. Its presence in drug formulations, even in trace amounts, needs to be monitored and controlled as per regulatory guidelines. Utilizing Celecoxib Impurity B as a reference standard allows analytical chemists to develop and validate methods (e.g., HPLC, GC) capable of accurately detecting and quantifying this specific impurity in drug samples. This ensures that the final product complies with safety and efficacy standards.

The importance of these standards cannot be overstated. They are essential for:

  • Method Validation: Demonstrating the accuracy, precision, specificity, and linearity of analytical methods.
  • Routine Testing: Quantifying the levels of specific impurities in batch release testing.
  • Stability Studies: Assessing the degradation pathways of a drug product over time.
  • Regulatory Submissions: Providing evidence of impurity control to health authorities.

For pharmaceutical developers and manufacturers, sourcing these vital reference materials requires partnering with reputable suppliers. NINGBO INNO PHARMCHEM CO.,LTD., a leading manufacturer and supplier in China, specializes in providing high-purity fine chemicals and pharmaceutical intermediates. We offer Celecoxib Impurity B (CAS 331943-04-5) that is rigorously tested to ensure it meets the stringent requirements of pharmaceutical QA/QC. When you buy Celecoxib Impurity B from us, you are investing in the reliability and compliance of your products.

We understand that consistency and availability are critical. As an established manufacturer, we maintain efficient production and inventory management. Our commitment extends to offering competitive pricing, particularly for bulk orders. We encourage research scientists and procurement managers to inquire about our product catalog and discover how partnering with NINGBO INNO PHARMCHEM CO.,LTD. can support your pharmaceutical development goals. Contact us today to get a quote and secure your supply of this essential reference standard.