MICROBIOLOGICAL QUALITY ASSESSMENT OF “CIPROMAX-AK” POWDER FOR ORAL SUSPENSION ACCORDING TO USP AND USP
- Информация о материале
- Категория: 2026 год
«Инфекция, иммунитет и фармакология» · № 5/2026 · с. 132–142
Turgunov Dilshod Ma’murjonovich, Yunuskhodjaeva Nodira Abdulhamidovna
Kokand University, Andijan Branch, Andijan, Uzbekistan
Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Education and Research, Tashkent, Uzbekistan
Abstract
Background. Microbiological purity is a mandatory and very essential quality attribute of non-sterile oral medicines, and it deserves particular attention in antibacterial powders that are made with water to make solution and administered mostly to children and minors. Aim. To create the microbiological quality of a locally manufactured powder for oral suspension, “Cipromax-AK” 125 mg/5 mL (60 mL) by Askam Pharma , against the harmonised requirements of USP <61> and USP <62>. Methods. A sample from a newly introduced production series of AS-KAM Pharma LLC (Uzbekistan) was examined at the Andijan branch testing laboratory of the Center for Safety of Pharmaceutical Products between 12 and 19 August 2026. Total aerobic microbial count (TAMC) and total combined yeasts and moulds count (TYMC) were determined according to USP <61>, and the absence of Escherichia coli in 1 g was verified according to USP <62>. Results were interpreted against the USP <1111> criteria for non-aqueous preparations for oral use. Results. Both TAMC and TYMC were below 10 CFU/g, the lowest count quantifiable at the dilution used, which places them at least 2.0 and 1.0 log₁₀ units below the respective limits of 10³ and 10² CFU/g. E. coli was not detected in 1 g of product which means very good. Conclusion. The checked series complied with requirements on Uzbek pharmacopoeia and USP for microbiological quality. Because the product contains an antibacterial substance, documented neutralisation and recovery data remain an essential condition for the reliability of such results; testing of other commercial series and of the water added suspension during in-use storage is recommended.
Keywords: non-sterile pharmaceutical products; microbial enumeration; total aerobic microbial count; yeasts and moulds; Escherichia coli; USP <61>; USP <62>; powder for oral suspension; quality control; Uzbekistan.