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Acid number (IA) is a number that expresses the amount of potassium hydroxide required to neutralize free fatty acids present in 1 g of sample and is an important factor in determining the degree of refining, the quality of fats and oils, and the assessment of the correctness of their storage conditions. Many oils of plant or animal origin can be used in medicine, due to their medicinal properties, but they can also be used as pharmaceutical raw materials, most often as a basis for the production of other preparations and then must be of pharmacopoeial quality, and accordingly tests are carried out according to individual monographs prescribed by the relevant pharmacopoeias. According to the general regulation of the Ph. Eur. 11, the acid number is determined by titration of a sample dissolved in a mixture of ethanol (96%) and petroleum ether, 0.1 M KOH using phenolphthalein as an indicator, and details related to the individual sample are given in the individual monographs. The aim of this work is to determine the acid number in fatty oils that are used as pharmaceutical raw materials for the production of master preparations in the pharmacy. The obtained results will be compared with the data specified in the manufacturer's certificate, which is binding for every raw material pharmaceutical technology. Also, the goal is to determine the acid number in commercial St. John’s wort oil made using sunflower oil as a carrier, and to compare it with the acid number of expired oil from the same manufacturer, in which there was a change in color and smell. The following results were obtained: acid value of virgin castor oil 1.1175, hydrogenated olive oil 0.3334, or fish oil 0.0668, which corresponds to the manufacturer's specifications. It can be concluded that the oils used in the production of master pharmaceutical preparations are of good quality and are in accordance with the results of the manufacturer's analyses. Regarding the last two samples from the obtained results (acid number of sample 4 is 4.4749 and sample 5 is 0.1118, which is about 40 times higher content of free fatty acids), it can be concluded that the shelf life has a great influence on increasing the content of free fatty acids, and improper storage and multiple opening of the preparation are also factors that accelerate oxidation.

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Acid Number as an Indicator of the Quality of Vegetable Oils Used as Pharmaceutical Raw Materials

  • 会议论文

  • 发表日期：

    2026年

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  • Emira Mlivo,
  • Alija Uzunović,
  • Minela Dacić,
  • Saša Pilipović,
  • Kemal Durić,
  • Berina Pilipović

摘要

Acid number (IA) is a number that expresses the amount of potassium hydroxide required to neutralize free fatty acids present in 1 g of sample and is an important factor in determining the degree of refining, the quality of fats and oils, and the assessment of the correctness of their storage conditions. Many oils of plant or animal origin can be used in medicine, due to their medicinal properties, but they can also be used as pharmaceutical raw materials, most often as a basis for the production of other preparations and then must be of pharmacopoeial quality, and accordingly tests are carried out according to individual monographs prescribed by the relevant pharmacopoeias. According to the general regulation of the Ph. Eur. 11, the acid number is determined by titration of a sample dissolved in a mixture of ethanol (96%) and petroleum ether, 0.1 M KOH using phenolphthalein as an indicator, and details related to the individual sample are given in the individual monographs. The aim of this work is to determine the acid number in fatty oils that are used as pharmaceutical raw materials for the production of master preparations in the pharmacy. The obtained results will be compared with the data specified in the manufacturer's certificate, which is binding for every raw material pharmaceutical technology. Also, the goal is to determine the acid number in commercial St. John’s wort oil made using sunflower oil as a carrier, and to compare it with the acid number of expired oil from the same manufacturer, in which there was a change in color and smell. The following results were obtained: acid value of virgin castor oil 1.1175, hydrogenated olive oil 0.3334, or fish oil 0.0668, which corresponds to the manufacturer's specifications. It can be concluded that the oils used in the production of master pharmaceutical preparations are of good quality and are in accordance with the results of the manufacturer's analyses. Regarding the last two samples from the obtained results (acid number of sample 4 is 4.4749 and sample 5 is 0.1118, which is about 40 times higher content of free fatty acids), it can be concluded that the shelf life has a great influence on increasing the content of free fatty acids, and improper storage and multiple opening of the preparation are also factors that accelerate oxidation.