In the pharmaceutical industry, the precise identification and quantification of impurities are critical for ensuring drug safety, efficacy, and regulatory compliance. For the widely prescribed antidiabetic drug Glimepiride, various impurities can arise during synthesis or degradation. One such compound, known as Glimepiride EP Impurity B or Glimepiride Related Compound B, is chemically identified as 4-[2-[(3-Ethyl-4-methyl-2-oxo-3-pyrrolin-1-yl)carboxamido]ethyl]benzenesulfonamide, with the CAS number 119018-29-0. As a leading supplier of pharmaceutical reference standards and specialized intermediates, we understand the rigorous requirements of QC departments and R&D labs. This article provides insights for procurement managers and analytical scientists seeking to buy high-purity standards of this specific Glimepiride intermediate.

Understanding Glimepiride Impurity B (CAS: 119018-29-0)

Glimepiride EP Impurity B (CAS: 119018-29-0) is a well-characterized chemical entity that can be present as an impurity in Glimepiride drug substances or products. Its structural similarity to Glimepiride makes it a relevant marker for process control and quality assessment. For analytical purposes, such as method validation, system suitability testing, and routine quality control (QC), access to highly pure reference standards of Impurity B is indispensable. Analytical scientists require materials with documented purity, typically exceeding 97%, and comprehensive characterization data to accurately develop and validate their analytical methods (e.g., HPLC).

Key Factors for Sourcing Impurity Standards

When procuring reference standards like Glimepiride Impurity B (CAS: 119018-29-0), several critical factors must be considered by pharmaceutical companies:

  • Purity and Characterization: The standard must be of very high purity, with accompanying analytical data confirming its identity and purity. This typically includes NMR, LC-MS, and purity by HPLC or GC. Suppliers should provide detailed Certificates of Analysis (CoA).
  • Supplier Reputation: Choose suppliers with a strong reputation for providing reliable pharmaceutical reference standards. Companies that specialize in impurities and metabolites often have more robust processes for characterization and certification.
  • Regulatory Compliance: Ensure the supplier can provide documentation that supports regulatory filings. Standards traceable to pharmacopeial sources (like USP or EP) are highly valued.
  • Availability and Lead Time: For critical QC applications, the availability of the standard and timely delivery are crucial. Manufacturers should have robust inventory management or efficient synthesis capabilities.
  • Packaging and Storage: Proper packaging and clear storage instructions (e.g., sealed, dry, room temperature) are necessary to maintain the integrity of the reference standard.

Our Commitment to Quality Reference Standards

NINGBO INNO PHARMCHEM CO.,LTD. is a trusted manufacturer and supplier dedicated to providing high-quality pharmaceutical intermediates and reference standards. We offer Glimepiride EP Impurity B (CAS: 119018-29-0) with exceptional purity and comprehensive analytical documentation, suitable for demanding QC and R&D applications. Our commitment to rigorous quality control ensures that you receive materials that meet the highest pharmacopeial expectations. We understand the critical nature of reference standards in ensuring drug product quality and compliance. For procurement managers and analytical scientists, partnering with us means gaining access to reliable, well-characterized standards that facilitate accurate analysis and regulatory approval. Contact us today to inquire about pricing, availability, and to obtain a sample of our Glimepiride Impurity B standard.