Safer Solvents for Active Pharmaceutical Ingredient Purification Using Column Chromatography

IF 6.7 Q1 ENGINEERING, ENVIRONMENTAL ACS Environmental Au Pub Date : 2024-06-24 DOI:10.1021/acsenvironau.4c00015

Christian Ayafor, Toren Burton, Nathaniel George, Gregory Morose, Hsi-Wu Wong

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Abstract

Column chromatography is a technique widely used for the purification of active pharmaceutical ingredients (APIs). One of the common solvent systems used by this technique is blends of dichloromethane (DCM) and methanol (MeOH), thereby exposing workers to health and safety risks and making the pharmaceutical sector one of the major contributors to chlorinated solvent waste. In this work, API separation and purification using several alternative safer solvent blends in column chromatography were evaluated and compared to DCM/MeOH. Ibuprofen and acetaminophen were used as model APIs, and caffeine was used as a model additive. Overall, some of the safer solvent blends tested provided better performance, with higher API recovery and purity compared to DCM/MeOH, in addition to potential health, safety, and environmental benefits. Specifically, blends of heptane/ethyl acetate and heptane/methyl acetate showed the most promise. Our work demonstrates the potential of these safer solvent blends as possible replacements for DCM/MeOH in API purification, thereby addressing a critical safety concern in the pharmaceutical industry.

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使用柱色谱法纯化活性药物成分的更安全溶剂

柱层析是一种广泛用于纯化活性药物成分 (API) 的技术。这种技术常用的溶剂系统之一是二氯甲烷（DCM）和甲醇（MeOH）的混合物，从而使工人面临健康和安全风险，并使制药行业成为产生含氯溶剂废物的主要行业之一。在这项工作中，对柱层析中使用几种更安全的混合溶剂进行原料药分离和纯化进行了评估，并与 DCM/MeOH 进行了比较。布洛芬和对乙酰氨基酚被用作示范原料药，咖啡因被用作示范添加剂。总体而言，与 DCM/MeOH 相比，一些经测试的更安全溶剂混合物性能更好，原料药回收率和纯度更高，此外还具有潜在的健康、安全和环境效益。具体来说，庚烷/醋酸乙酯和庚烷/醋酸甲酯的混合物最有前景。我们的研究表明，这些更安全的混合溶剂有可能在原料药提纯过程中替代 DCM/MeOH，从而解决制药行业的一个关键安全问题。

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来源期刊

ACS Environmental Au 环境科学-

CiteScore

7.10

自引率

0.00%

发文量

期刊介绍： ACS Environmental Au is an open access journal which publishes experimental research and theoretical results in all aspects of environmental science and technology both pure and applied. Short letters comprehensive articles reviews and perspectives are welcome in the following areas:Alternative EnergyAnthropogenic Impacts on Atmosphere Soil or WaterBiogeochemical CyclingBiomass or Wastes as ResourcesContaminants in Aquatic and Terrestrial EnvironmentsEnvironmental Data ScienceEcotoxicology and Public HealthEnergy and ClimateEnvironmental Modeling Processes and Measurement Methods and TechnologiesEnvironmental Nanotechnology and BiotechnologyGreen ChemistryGreen Manufacturing and EngineeringRisk assessment Regulatory Frameworks and Life-Cycle AssessmentsTreatment and Resource Recovery and Waste Management