Quality Control and Specifications for Pharmaceutical Intermediates: A Focus on 5-Chloro-2-Thiophenecarboxylic Acid
In the highly regulated pharmaceutical industry, the quality of every component, especially chemical intermediates, is non-negotiable. 5-Chloro-2-thiophenecarboxylic acid (CAS No.: 24065-33-6), a crucial intermediate for the anticoagulant Rivaroxaban, exemplifies the rigorous quality standards that must be met. Pharmaceutical manufacturers rely on intermediates with precise specifications to ensure the safety, efficacy, and consistency of their final drug products. NINGBO INNO PHARMCHEM CO.,LTD. places paramount importance on quality control throughout its production of this vital chemical.
Key quality parameters for 5-Chloro-2-thiophenecarboxylic acid typically include assay purity, appearance, moisture content, and the absence of specific impurities. A common specification for assay purity is ≥97.0%, often determined by methods like High-Performance Liquid Chromatography (HPLC) or Gas Chromatography (GC). The appearance is usually described as a white to light yellow crystalline powder. Moisture content, often limited to ≤0.5% (loss on drying), is critical for product stability and reactivity in subsequent synthesis steps.
Manufacturers must implement stringent quality control measures at every stage of production, from raw material sourcing to final product packaging. This often involves in-house analytical laboratories equipped with advanced instrumentation to perform routine testing and ensure compliance with specifications. Certificates of Analysis (CoA) are essential documents provided to customers, detailing the results of these quality tests for each batch. For a critical intermediate like 5-Chloro-2-thiophenecarboxylic acid, these CoAs are vital for regulatory compliance and customer confidence.
Choosing a 5-Chloro-2-thiophenecarboxylic acid manufacturer that demonstrates a robust quality management system is crucial. NINGBO INNO PHARMCHEM CO.,LTD. is committed to upholding these high standards, ensuring that every batch of 5-Chloro-2-thiophenecarboxylic acid supplied meets the demanding requirements of the pharmaceutical sector. This dedication to quality control not only ensures product integrity but also supports the reliable production of essential medicines that benefit patients worldwide.
Perspectives & Insights
Quantum Pioneer 24
“The appearance is usually described as a white to light yellow crystalline powder.”
Bio Explorer X
“5% (loss on drying), is critical for product stability and reactivity in subsequent synthesis steps.”
Nano Catalyst AI
“Manufacturers must implement stringent quality control measures at every stage of production, from raw material sourcing to final product packaging.”