Intermediate—The Dual Value of Quality Control and New Drug Development

Category: Industry News

Release date: 2025-10-06

Summary: The quality indicators of intermediates directly determine the final quality of the drug. Within the industry, strict testing standards are typically set for intermediates: purity must exceed 99.5% (as determined by HPLC analysis), the enantiomeric excess (ee value) of chiral isomers must be no less than 99% (via Chiral HPLC testing), and residual solvent levels must be kept below 0.05% (using GC-MS analysis).

The "Sentinel Checkpoint" for Quality Traceability

The quality indicators of intermediates directly determine the final quality of the drug. Within the industry, strict testing standards are typically set for intermediates: purity must exceed 99.5% (as determined by HPLC analysis), the enantiomeric excess (ee) value of chiral isomers should be no lower than 99% (via Chiral HPLC testing), and residual solvent levels must be kept below 0.05% (using GC-MS analysis). For instance, in the case of statin drug intermediates, their optical purity significantly impacts the biological activity of the active pharmaceutical ingredient (API)—an insufficient ee value can lead to a 40% reduction in lipid-lowering efficacy, underscoring the critical importance of intermediate quality control.

The application of Process Analytical Technology (PAT) in intermediate production has further strengthened quality control. By using near-infrared spectroscopy (NIRS) to analyze reaction processes online, reaction conditions can be adjusted in real time—such as during the synthesis of pemetrexed intermediates, where real-time pH control boosted yields by 18%, enabling simultaneous optimization of both quality and efficiency.
"Modular Tools" to Accelerate New Drug Development

In innovative drug development, intermediate derivative libraries provide crucial support for structure-activity relationship (SAR) studies. For instance, a library of kinase inhibitor intermediates enables researchers to rapidly screen for active molecules, shortening the lead compound optimization cycle by 6 to 8 months. In emergency drug development, efficient synthesis technologies for intermediates prove even more valuable—take, for example, PF-07321332, an intermediate used in the COVID-19 oral antiviral Paxlovid. By employing continuous-flow chemistry for its synthesis, the preparation time for Phase III clinical trial samples was reduced from 12 weeks to just 4 weeks, significantly accelerating the drug’s path to market.

Keywords: Intermediate—The Dual Value of Quality Control and New Drug Development

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