Determination of Organic Volatile Impurities in Twenty-Three Different Coated Tablet Formulations Using Headspace Gas Chromatography with Flame Ionization Detection Technique

Latif, Ayesha; Makhdoom, Humera Shafi; Imran, Muhammad; Mazhar, M.; Anwar, Emman; Sarwar, Mohammad; Tahir, Muhammad

doi:10.4172/2153-2435.1000553

Cited by 4 publications

(4 citation statements)

References 1 publication

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“…When using solvents known to be excessively toxic, it is best to avoid them unless justified by a risk-benefit analysis. The level of residual solvents is regulated by national and international norms, such as those set forth by the International Conference on Harmonization and the FDA, due to their demonstrated or potential toxicity [2].…”

Section: Figure 1 Sources Of Residual Solventsmentioning

confidence: 99%

Unmasking the purity: reviewingsources and detection methods of organic volatile impurities

Endluri,

Sakhinamma,

Chandra

2023

Int. J. Clin. Pharm. Med. Sci.

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Organic Volatile Impurities (OVIs) are residual solvents present in pharmaceutical products as a byproduct of the manufacturing process. These solvents, used in the creation of pharmacological compounds and excipients, often remain in trace amounts in the final medicinal formulations. Their presence is not only a matter of product purity but also of safety, as OVIs can pose significant health risks and environmental hazards. This paper delves into the classification of these residual solvents based on their toxicity levels, offering insights into which solvents are most hazardous and thus require stringent control. It emphasizes the importance of meticulously analyzing these impurities as a critical aspect of quality control in drug production. Additionally, the discussion extends to the methods typically employed for evaluating OVIs, highlighting the limitations of standard production techniques in completely removing these solvents. This leads to a consideration of strategies for minimizing the use of organic solvents in pharmaceutical manufacturing, an essential step towards safer and more sustainable practices. The paper concludes with a look at future trends in detecting and managing OVIs, indicating ongoing developments in this important area of pharmaceutical research and quality assurance.

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Section: Figure 1 Sources Of Residual Solventsmentioning

confidence: 99%

Unmasking the purity: reviewingsources and detection methods of organic volatile impurities

Endluri,

Sakhinamma,

Chandra

2023

Int. J. Clin. Pharm. Med. Sci.

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“…Residual solvents (RS) also called volatile organic compounds (VOCs) or organic volatile impurities (OVIs) are chemical impurities produced during pharmaceutical processes such as the manufacture of APIs [26]. They are undesirable substances that are hazardous to human health and have the ability to modify the properties of certain compounds [10]. Furthermore, they affect physicochemical properties like the crystallinity of bulk drug, which in turn affect the dissolution properties, color changes in the finished products [26].…”

Section: Residual Solventsmentioning

confidence: 99%

“…Residual solvents or residual organic solvents (ROS) in pharmaceuticals, also commonly known as organic volatile impurities (OVIs) or volatile organic compounds (VOCs), are chemicals that are either used or produced during the pharmaceutical process such as manufacturing of APIs, excipients, drug formulation [9]. It has been reported [10] that OVIs are a potential risk for the quality and stability of drug products, as well as the human body if intake exceeds the permitted daily exposure (PDE). It is no longer a hidden fact that the wide occurrence of organic contaminants in wastewater poses a severe threat to public health regulatory bodies and ecosystems [11,12].…”

Section: Introductionmentioning

confidence: 99%

A Review on Electrochemical Degradation and Biopolymer Adsorption Treatments for Toxic Compounds in Pharmaceutical Effluents

et al. 2020

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Pharmaceutical industries generate very large quantities of toxic organic compounds which include volatile organic compounds (VOCs) and/or organic volatile impurities (OVIs). These toxic compounds, amongst which are emerging residual solvents, largely come from wastewater treatment plants (WWTPs) and are being continuously dumped into the environment at an alarming rate. Efficient treatment of pharmaceutical wastewaters (effluents) is currently a major challenge because of not only the enormous quantity to be disposed of but also its complexity, as well as its hazardous nature. Dumping these kinds of polluted wastes into the environment at uncontrolled rates are putting increasing pressure on freshwater ecosystems. This review paper focuses on combined electrochemical degradation and biopolymer adsorption treatment processes and techniques for toxic compounds in pharmaceutical wastewater treatment. These emerging processes such as the combination of electrochemical techniques as a primary treatment method, followed by an adsorption process, is now a topic of intense research as it is proving to very feasible, ecofriendly, and cost-effective in the complete recovery of toxic residual solvents from binary aquatic systems. This paper presents major toxic pollutants in pharmaceutical wastewaters and their fate in the aquatic environment, their sources, and origin in pharmaceutical industries. The evaluation of the traditional methods used for the removal of these emerging organic pollutants from aquatic matrices and pharmaceutical effluents is accomplished. New developments in electrochemical treatments for the remediation of toxic compounds in pharmaceutical wastewaters are also discussed.

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“…These residual solvents tend to cause toxic effects on patients and change drug characteristics, including changes in the release and permeability of the drug [2]; therefore, it is necessary to limit the number of organic solvent residues in tablet preparations. Limitation of the amount of solvent residue in tablets is carried out by measuring the residual solvent level to be compared with the ICH (International Conference on Harmonization) guidelines, issued by the harmonization conference of technical requirements to determine the limit of solvent residues that remain in active ingredients, excipients, and finished drug products [3]. In the previous study, amoxicillin tablet contained dichloromethane and toluene as residual solvents.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Residual Solvents in Co-amoxiclav Coated Tablets Using Solid Phase Microextraction–Gas Chromatography

Hanwar¹,

Arsanti²,

Primaharinastiti³

et al. 2022

Atlantis Highlights in Chemistry and Pharmaceutical Sciences

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Co-Amoxiclav tablets are coated tablets. The tablet coating process requires an organic solvent in the sealing stage. Several processes are carried out to remove organic solvents in the finished drug product, such as heating and pressure reduction, which still leaves organic solvents in the finished drug preparation. The purpose of this study was to optimize the solid phase microextraction method-gas chromatography for the analysis of organic solvent residues in co-amoxiclav tablets and the determination of the residual solvent content. The extraction method used was the headspace-SPME method, sample extraction by heating so that the solvent residue evaporated and absorbed by the PDMS-DVB (Polydimethylsiloxane-divinylbenzene) fiber. The extraction process was carried out by optimizing the temperature and time. The gas chromatography system used was the detector temperature of 250 °C, and the injected port temperature was 210 °C. The oven temperature was programmed, ranging from 38 °C to 210 °C with a temperature increase of 10 °C/min with a holding time of five minutes. The helium carrier gas flow rate was 0.71 mL/min. Analysis of residual solvent was conducted by looking at the retention time and peak area then comparing them with the standard solution. The optimal temperature and time of the extraction using SPME were 50 °C and 30 min. The residue analysis results showed that the co-amoxiclav coated tablets contained 2.88 ± 0.58 ppm dichloromethane residues.

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Determination of Organic Volatile Impurities in Twenty-Three Different Coated Tablet Formulations Using Headspace Gas Chromatography with Flame Ionization Detection Technique

Cited by 4 publications

References 1 publication

Unmasking the purity: reviewingsources and detection methods of organic volatile impurities

Unmasking the purity: reviewingsources and detection methods of organic volatile impurities

A Review on Electrochemical Degradation and Biopolymer Adsorption Treatments for Toxic Compounds in Pharmaceutical Effluents

Analysis of Residual Solvents in Co-amoxiclav Coated Tablets Using Solid Phase Microextraction–Gas Chromatography

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