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Particulate contamination in solutions of antibiotics packed as dry powders in vials
1Department of Pharmacy, University of Durban-Westville, Republic of South Africa.
Abstract:
The particulate contamination in 12 formulations of antibiotic solutions in vials packed as dry powders from five South African sources has been analysed quantitatively using a HIAC PC 320 light blockage particle analyser linked to a CMB 60 sensor. Results showed that the level of particulate contamination fell well within the limits set by the USP XXIst Edition for Small Volume Parenterals although four formulations contained some particles greater than or equal to 50 micron. There was no apparent difference between the quality of the same antibiotics from different sources or between vials of the same antibiotics packed in different strengths.
Insights
Particulate contamination in South African antibiotic solutions met United States Pharmacopeia (USP) standards. While most vials were compliant, some contained particles exceeding 50 microns, indicating a need for continued quality monitoring.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
Background:
- Particulate contamination is a critical quality attribute for parenteral drug products.
- Ensuring sterility and safety of injectable medications is paramount in healthcare.
Purpose of the Study:
- To quantitatively analyze particulate contamination in antibiotic solutions from South African sources.
- To compare contamination levels against established regulatory standards, specifically the United States Pharmacopeia (USP).
Main Methods:
- Utilized a HIAC PC 320 light blockage particle analyzer.
- Employed a CMB 60 sensor for quantitative particle analysis.
- Analyzed 12 formulations of antibiotic solutions in vials from five different South African manufacturers.
Main Results:
- Particulate contamination levels were generally within USP XXIst Edition limits for Small Volume Parenterals.
- Four of the analyzed formulations contained particles measuring 50 microns or larger.
- No significant quality differences were observed between antibiotics from different sources or varying strengths.
Conclusions:
- The analyzed antibiotic solutions largely meet established quality standards for particulate matter.
- The presence of larger particles in a subset of formulations warrants further investigation and quality control.
- Manufacturing source and drug strength did not appear to influence the level of particulate contamination.