DOI: https://doi.org/10.22263/2312-4156.2026.1.67
S.S. Malchenkova
Chemical stability of zinc sulfate solutions with ascorbic acid ex tempore for using on the oral mucosa
Belarusian State Medical University, Minsk, Republic of Belarus
Vestnik VGMU. 2026;25(1):67-78.
Abstract.
Objectives. To establish chemical stability of a pharmaceutical for use on the oral mucosa 0.25% zinc sulfate aqueous solution with 0.5% ascorbic acid and 10% glycerol oral rinses.
Material and Methods. The required volumes of medicinal products were prepared by a Minsk pharmacy. The chemical stability study of the solutions included evaluation of samples for quantitative zinc sulfate and ascorbic acid content, clarity, coloration, and pH. Active ingredient zinc sulfate and ascorbic acid content were determined using pharmacopoeial complexometric and iodatomerric titration methods (State Pharmacopoeia of the Republic of Belarus II, Vol. 1, #6.2. Express Analysis of Extemporaneous Medicinal Products). The degree of solution coloration was determined as specified in State Pharmacopoeia of the Republic of Belarus II, Vol. 1, 2.2.2. Determination of the Degree of Coloration of Liquids.
Results. Glycerin as a stabilizer has been established to slow down the degradation of ascorbic acid in a zinc sulfate solution. A comparison of changes in ascorbic acid content during storage of three different formulations glycerol-free and containing 5% or 10% glycerol revealed statistically significant differences between groups: F(0.05; 1; 40)=4.09, p=0.0001.
Conclusions. According to chemical stability testing results the shelf life of the pharmacy preparation 0.25% zinc sulfate solution with 0.5% ascorbic acid and 10% glycerol is 30 days when stored protected from light in 450 ml colorless medical glass containers.
Keywords: shelf life, ascorbic acid, zinc sulfate, chemical stability, pharmacy preparations, glycerol.
References
1. Diagnosis and treatment of patients (child population) with eye diseases and their attachment: postanovlenie M-va zdravookhraneniya Resp Belarus' ot 12 sent 2023 g № 133. ETALON: inform-poiskovaya sistema. [Accessed 30th January 2026]. (In Russ.).
2. Diagnosis and treatment of patients (adult population) with benign diseases of the rectum, pararectal and coccygeal area in outpatient and hospital: postanovlenie M-va zdravookhraneniya Resp Belarus' ot 01 apr 2022 g № 22. ETALON: inform-poiskovaya sistema. [Accessed 30th January 2026]. (In Russ.).
3. Diagnosis and treatment of patients with otorhinolaryngological diseases (adult population): postanovlenie M-va zdravookhraneniya Resp Belarus' ot 01 iyunya 2017 g № 49. ETALON: inform-poiskovaya sistema. [Accessed 30th January 2026]. (In Russ.).
4. Kolyadich ZhV. Onco-epidemiological features of head and neck tumors in terms of competences of the otorhinolaryngological service by regions of the Republic of Belarus. Problemy Zdorov'ya i Ekologii. 2021;18(4):129-135. (In Russ.). doi: http://dx.doi.org/10.51523/2708-6011.2021-18-4-17
5. Parkhomenko LB. Prevention and treatment of mucositis in radiation therapy for cancer and head and neck. Zdravookhranenie. 2021;(1):24-32. (In Russ.).
6. Romanenko IG, Arakelyan KA, Salishcheva VO. Modern concepts of prevention and treatment of oral mucositis in oncotherapy. Vyatskii Meditsinskii Vestnik. 2021;(1):96-101. (In Russ.). doi: http://dx.doi.org/10.24411/2220-7880-2021-10161
7. Mehdipour M, Zenoz AT, Kermani IA, Hosseinpour A. A comparison between zinc sulfate and chlorhexidine gluconate mouthwashes in the prevention of chemotherapy-induced oral mucositis. Daru. 2011;19(1):71-73.
8. Smagunova AN, Karpukova OM. Statistical methods in analytical chemistry. 2-e izd, pererab i dop. Moscow, RF: Yurait; 2025. 364 р. (In Russ.).
9. Berezovskiy VM. Chemistry of vitamins. Izd 2-e. Moscow, RF: Pishchevaya promyshlennost'; 1973. 200 р.
10. Sheraz M, Khan M, Ahmed S, Kazi S, Ahmad I. Stability and Stabilization of Ascorbic Acid: A Review. Household and Personal Care Today. 2015 May-Jun;10(3):20-25.
11. Khadour A, Al Haushey L. Investigation of the effect of different formulation factors on the shelf life of Vitamin C in aqueous solutions. Research Jurnal of Pharmacy and Technology. 2024;17(8):3874-3880. doi: http://dx.doi.org/10.52711/0974-360X.2024.00601
12. Bandelini FJ, Tuschhoff JV. The Stability of Ascorbic Acid in Various Liquid Media. Journal of the American Pharmaceutical Association. 1955 Apr;44(4):241-244.
13. Ascorbic acid, 50 mg/ml, solution for intravenous and intramuscular administration: instruktsiya po primeneniyu. Gosudarstvennyi reestr lekarstvennykh sredstv Respubliki Belarus'. URL: https://www.rceth.by/Refbank/reestr_lekarstvennih_sredstv/details/23_07_216 [Accessed 30th January 2026]. (In Russ.).
14. Carr A, Wohlrab C, Young P, Bellomo R. Stability of intravenous vitamin C solutions: a technical report. Critical Care and Resuscitation. Crit Care Resusc. 2018 Sep;20(3):180-181.
15. Ascorbic acid 2%, 5%, 10% solution: prikaz Minzdrava Rossii ot 11 apr 2025 g № 188. Institut farmakopei i standartizatsii v sfere obrashcheniya lekarstvennykh sredstv. URL: https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/3/3-6/askorbinovoy-kisloty-2-5-10-rastvor/?sphrase_id=1492445 [Accessed 30th January 2026]. (In Russ.).
Submitted 14.11.2025
Accepted 16.02.2026
Information about authors:
Svetlana S. Malchenkova – senior lecturer of the Chair of the Pharmaceutical Technology with the course of the Faculty for Advanced Training & Retraining, Belarusian State Medical University, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра..
