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Determination of Preservatives in Pharmaceuticals and Personal Care Products
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 Title & Authors
Determination of Preservatives in Pharmaceuticals and Personal Care Products
Kim, Boyoung; Lee, Joohee; Kim, Seonyeob; Lee, Eunji; Choi, Chorong; Kho, Younglim;
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Objectives: Preservatives are commonly used in pharmaceuticals, cosmetics and other products to extend the expiration date and prevent the growth of microorganisms. Preservatives are generally effective in controlling mold and inhibiting yeast growth, and against a wide range of bacterial attacks as well. They also adversely affect the quality of sperm and cause precocious puberty in children. This study was performed to analyze seven preservatives used in pharmaceuticals and personal care products. Methods: Five kinds of pharmaceuticals and personal care products (PPCPs) were examined for analysis with a high performance liquid chromatography-diode array detector. Each sample was homogenized and the targeted compounds were extracted with methanol. The suspended particulate was removed by syringe filter. Next, the sample was injected into an HPLC system. The separation of the seven preservatives was achieved with a C18 column and gradient mode. The accuracies were between 73% and 120% and precision was lower than 11.58% (RSD). Results: All of the calibration curves showed good linearity with a coefficient of determination () over 0.999. Among the PPCP samples, the detection rate of preservatives was 32.5% for pharmaceuticals, 44.8% for toothpaste, 76.9% for mouthwash, 40.0% for body lotion and 56.0% for wet tissues. The average concentrations of the preservatives in PPCPs were BA 1141.0 mg/kg, MP 709.8 mg/kg, EP 624.9 mg/kg, PP 216.9 mg/kg, BP 167.8 mg/kg, and TCS 538.2 mg/kg. The most frequently detected preservatives in pharmaceuticals and personal care products were BA, MP and PP. The concentrations of preservatives exceeded Korean regulatory standards in 11 samples of medicines, three of mouthwash and two of body lotion. Conclusion: We found that most of the PPCP samples contained various preservatives. It is necessary to identify which preservatives were used and to determine the level of preservatives in PPCPs and to assess the health risk to susceptible populations such as children.
 Cited by
Lee YM. Optimization Plan of Use Standard for Preservatives. KFDA. 2008; 1. p.1-82.

Flores M, Morillo M, Crespo ML. Deterioration of raw materials and cosmetic products by preservative resistant microorganisms. International Biodeterioration & Biodegradation. 1997; 40(2-4): 157-160. crossref(new window)

Soni MG, Carabin IG, Burdock GA. Safety assessment of esters of p-hydroxybenzoic acid (parabens). Food and Chemical Toxicology. 2005; 43: 985-1015. crossref(new window)

Techakriengkrai I, Surakarnkul R. Analysis of benzoic acid and sorbic acid in Thai rice wines and distillates by solid-phase sorbent extraction and highperformance liquid chromatography. Journal of Food Composition and Analysis. 2007; (20): 220-225. crossref(new window)

Judson R, Richard A, Dix DJ, Houck K, Martin M, Kavlock R, et al. The Toxicity Data Landscape for Environmental Chemicals. Environmental Health Perspectives. 2009; 117(5)

Terasaki M, Makino M, Tatarazako N. Acute toxicity of parabens and their chlorinated by-products with Daphnia magna and Vibrio fischeri bioassays. Journal of Applied Toxicology. 2009; 29(3): 242-247. crossref(new window)

Sezginturk MK, Goktugw T, Dinc kaya E. Detection of Benzoic Acid by an Amperometric Inhibitor Biosensor Based on Mushroom Tissue Homogenate. Food Technology and Biotechnology. 2005; 43(4): 329-334.

Tfouni SAV, Toledo MCF. Determination of benzoic and sorbic acids in Brazilian food. Food Control. 2001; 13(2): 117-123. crossref(new window)

Martins I, Carreira FC, Canaes LS, Junior FASC, Cruz LMS, Rath S. Determination of parabens in shampoo using high performance liquid chromatography with amperometric detection on a borondoped diamond electrode. Talanta. 2011; 85(1): 1-7. crossref(new window)

Taxvig C, Vinggaard AM, Hass U, Axelstad M, Boberg J, Hansen PR, et al. Do Parabens Have the Ability to Interfere with Steroidogenesis? Toxicological sciences : an official. Journal of the Society of Toxicology. 2008; 106(1): 206-219. crossref(new window)

Alam MS, Ohsako S, Kanai Y, Kurohmaru M. Single administration of butylparaben induces spermatogenic cellapoptosis in prepubertal rats. Acta Histochemica. 2014; 116(3): 474-480. crossref(new window)

U.S. Food and Drug Administration, Triclosan: What Consumers Should Know. Available: [accessed 25 December 2015].

Park SP, Chung HJ, Kim YJ, Kim OS. Triclosan Inhibition of Prostaglandin E2 Production in Human Gingival Fibroblast. Journal of Korean Academy of Periodontology. 2014; 34(2): 345-356.

Available: [accessed 24 November 2015]

Choi NJ. A Survey on the safety of cosmetics, Korea consumer agency. 2002; 12: 50-71.

Huang HY, Lai YC, Chiu CW, Yeh JM. Comparing micellar electrokinetic chromatography and microemulsion electrokinetic chromatography for the analysis of preservatives in pharmaceutical and cosmetic products. Journal of Chromatography A. 2003; 993(1-2): 153-164. crossref(new window)

Yoo YJ. Simultaneous Analysis and Monitoring of Thirteen Preservatives in Cosmetics by Liquid Chromatography. [dissertation]. [Chungcheongbukdo Province]. Chungbuk National University; 2013

Jung SM, Moon TJ, Kim JD, Lee GW. Study on Simultaneous Analysis and Use of Preservatives in Mouthwashes. Joural of digital convergence. 2012; 10(6): 331-339.

WHO. Benzoic acid and sodium benzoate. Concise International Chemical Assessment Document 26. World Health Organization, Geneva, Switzerland; 2000. P.14-26.

Liao C, Kannan K. Concentrations and composition profiles of parabens in currency bills and paper products including sanitary wipes. 2012; 475: 8-15.