Microbiological purity determination of concentrated solutions of inorganic salts pharmaceutical preparation

O Shtrimaitis; O Zdoryk; O Strilets; V Georgiyants

Автор(и)

O Shtrimaitis National University of Pharmacy,
O Zdoryk National University of Pharmacy,
O Strilets National University of Pharmacy,
V Georgiyants National University of Pharmacy,

Ключові слова:

concentrated solutions of salts of inorganic acids, quality control, microbiological purity.

Анотація

Results of microbiological purity research of compounding concentrated solutions during the period of their storage period (1 month) under different temperature
conditions are given in the article. The tests were carried out according to requirements of the State Pharmacopoeia of Ukraine by direct two-layer sowing (national part). Experimentally there was found the absence of bacteria Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa. It is proved that all the analyzed samples of concentrated solutions meet the requirements regarding the quality of the water medicines for oral administration in accordance with the requirements of the State Pharmacopoeia of Ukraine.

Посилання

Zdoryk О.А. World experience of the expiration date determination of compounding preparations / О.А. Zdoryk // Pharmaceutical journal. – 2013. – № 6. – P. 42– 47.

State Pharmacopoeia of Ukraine / State Enterprise «Scientific and Expert Pharmacopoeial Centre». – 1st ed. Appendix 2. – Kharkov: RIREH, 2008. – 608 p.

Requirements for the preparation of non-sterile medicinal products in conditions of pharmacy: Guidelines (Approved by the order of Ministry of health of Ukraine dated August 03, 2005, № 391). – 2-еd. – Kyiv: The Ministry of health of Ukraine, 2005. – 98 p.

Stability study of the compounding preparation calcium chloride concentrated solution / O. V. Shtrimaitis, O. A. Zdoryk, V. A. Georgiyants // «Zbirnyk Naukovykh Prats’ Spivrobitnykiv NMAPO imeni P. L. Shupyka». – 2013. – № 22(4). – P. 323-328.

State Pharmacopoeia of Ukraine / State Enterprise «Scientific and Expert Pharmacopoeial Centre» – 1st ed. – Kharkov: RIREH, 2001. – 556 p.

State Pharmacopoeia of Ukraine / State Enterprise «Scientific and Expert Pharmacopoeial Centre» – 1st ed. Appendix 4. – Kharkov: RIREH, 2011. – 536 p.

Gemerova E.G. On the matter of drug microbiological purity control on accordance with GFU requirements. Report 1. Validation of methods for determining the total number of viable aerobic microorganisms/ E.G.

Gemerova, N.P. Khovanskaya // Pharmacom. – 2002. – № 3. – P. 51-55.

Gemerova E.G. On the matter of drug microbiological purity control on accordance with GFU requirements. Report 2. A validation test procedures for certain types of microorganism/ E.G. Gemerova, N.P. Khovanskaya //

Pharmacom.– 2003. – № 1. – P. 1-12.

Gunnar O.V. Risk of false microbiological results in the quality control of medicines/ O.V. Gunnar // Pharmacia. – 2005. – № 2. – P. 29–31.