Controlled Strategies and estimation of trace toxic solvents in pharmaceuticals

Dharmpal Singh; Prachi Diwakar; Priyanka Mathur

doi:10.36948/ijfmr.2026.v08i02.71536

Controlled Strategies and estimation of trace toxic solvents in pharmaceuticals

Author(s)	Mr. Dharmpal Singh, Prof. Prachi Diwakar, Prof. Priyanka Mathur
Country	India
Abstract	Residual solvents in pharmaceuticals refer to volatile organic chemicals that are used during the manufacture of drug substances and finished drug products. Solvents play an essential role in producing active pharmaceutical ingredients (APIs) and drug products, as their proper selection can improve reaction efficiency and influence important properties such as crystal structure, purity, and solubility. Because solvents and their related impurities are integral to the manufacturing process, they may not be fully eliminated during processing and can remain in the final product. As a result, controlling residual solvents is a critical aspect of pharmaceutical development and manufacturing. Tests for residual solvents are generally not specified in individual monographs because the types of solvents used may differ between manufacturers. These solvents can pose risks not only to the environment but also to patient safety if present above acceptable levels. Therefore, acceptable limits for residual solvents are established in the ICH guideline Q3C (R9). This guideline classifies residual solvents into three categories based on their potential risk to human health, taking into account toxicity data and environmental concerns. Class 1 solvents—including benzene (2 ppm), carbon tetrachloride (4 ppm), 1,2-dichloroethane (5 ppm), 1,1-dichloroethane (8 ppm), and 1,1-trichloroethane (1500 ppm)—should be avoided in pharmaceutical manufacturing because they are recognized human carcinogens, highly toxic, and environmentally hazardous, with some also contributing to ozone depletion. Nevertheless, trace amounts of these solvents may still be present as impurities in other commonly used solvents. For example, benzene may be found in ethanol, methanol, acetone, and isopropyl alcohol, while 1,1-dichloroethane and 1,1-trichloroethane may occur in dichloromethane. Therefore, it is essential to carefully monitor and strictly control the levels of these harmful solvents in the solvents used during pharmaceutical manufacturing.
Keywords	Gas chromatography (GC), Genotoxic impurity and carcinogenic impurity
Field	Chemistry
Published In	Volume 8, Issue 2, March-April 2026
Published On	2026-03-20
DOI	https://doi.org/10.36948/ijfmr.2026.v08i02.71536

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Controlled Strategies and estimation of trace toxic solvents in pharmaceuticals

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