Navigating Pharmaceutical Impurities: The Role of CAS 402824-96-8
The pharmaceutical industry operates under a strict framework of quality control, where the presence and levels of impurities in drug substances are meticulously monitored. For Hydrochlorothiazide, a widely prescribed medication, understanding its impurities is a critical aspect of drug development and manufacturing. CAS number 402824-96-8 identifies Hydrochlorothiazide EP Impurity C, a compound of significant interest to regulatory bodies and quality assurance professionals.
Hydrochlorothiazide EP Impurity C, also known as the Hydrochlorothiazide dimer, is a substance that needs careful management. Its characterization as a specific impurity means that its presence must be accurately quantified to ensure that the final Hydrochlorothiazide product meets all safety and efficacy standards. This is where the role of a reliable pharmaceutical impurity reference standard becomes indispensable. By providing a precisely known quantity and purity of this impurity, reference standards enable laboratories to validate their analytical methods and confirm the purity of their API batches.
The chemical properties of CAS 402824-96-8 are well-documented. With a molecular formula of C15H16Cl2N6O8S4 and a molecular weight of 607.49 g/mol, it typically presents as a white to off-white solid. Its solubility characteristics in common laboratory solvents, such as DMSO and methanol, are crucial for its application in chromatographic techniques like HPLC. The process for the chemical synthesis of Hydrochlorothiazide impurity C is specialized, and obtaining it from reputable suppliers is key for accurate Hydrochlorothiazide quality control.
For pharmaceutical companies, the ability to buy Hydrochlorothiazide EP Impurity C is essential for robust quality management systems. It is used in various stages, including the validation of analytical methods to detect and quantify the impurity, stability studies to understand how impurity levels change over time, and routine batch release testing. Adhering to ICH guidelines and pharmacopoeial standards necessitates the use of such well-defined impurity markers. Ningbo Inno Pharmchem Co., Ltd. is committed to supporting these efforts by supplying high-quality reference standards like CAS 402824-96-8.
In essence, CAS 402824-96-8, Hydrochlorothiazide EP Impurity C, plays a vital role in upholding the integrity of Hydrochlorothiazide products. Its precise characterization and availability as a reference standard empower the pharmaceutical industry to maintain stringent quality control, ensuring patient safety and regulatory compliance. Understanding and utilizing these critical impurity standards is fundamental to pharmaceutical excellence.
Perspectives & Insights
Chem Catalyst Pro
“The process for the chemical synthesis of Hydrochlorothiazide impurity C is specialized, and obtaining it from reputable suppliers is key for accurate Hydrochlorothiazide quality control.”
Agile Thinker 7
“For pharmaceutical companies, the ability to buy Hydrochlorothiazide EP Impurity C is essential for robust quality management systems.”
Logic Spark 24
“It is used in various stages, including the validation of analytical methods to detect and quantify the impurity, stability studies to understand how impurity levels change over time, and routine batch release testing.”