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Microbiological quality of pharmaceutical raw materials
M C de la Rosa1, M R Medina, C Vivar
1Departamento de Microbiología II, Facultad de Farmacia, Universidad Complutense de Madrid, Ciudad Universitaria, Spain.
Pharmaceutica Acta Helvetiae
|September 1, 1995
Summary
Microbiological analysis of pharmaceutical excipients found most samples met standards. However, Arabic gum and tragacanth gum showed higher contamination, with some bacterial and fungal presence detected.
Area of Science:
- Microbiology
- Pharmaceutical Science
- Quality Control
Background:
- Pharmaceutical excipients are crucial inactive ingredients in drug formulations.
- Ensuring the microbiological purity of excipients is vital for patient safety and drug efficacy.
- Regulatory bodies like the European Pharmacopoeia and USP set strict microbiological limits for pharmaceutical raw materials.
Purpose of the Study:
- To assess the microbiological quality of commonly used pharmaceutical excipients.
- To identify specific excipients with higher contamination levels.
- To determine compliance with established European Pharmacopoeia and USP microbiological standards.
Main Methods:
- Analysis of 115 pharmaceutical raw material samples, including lactose, talc, corn starch, arabic gum, gelatin, gelatinized starch, cellulose, and tragacanth gum.
- Microbiological testing for bacterial and fungal contamination (colony-forming units per gram).
- Specific pathogen testing for Escherichia coli, Salmonella-Shigella, Enterobacter, Serratia, and Proteus.
Main Results:
- 69.9% of samples had <10(2) bacteria/g (mean 23.2 cfu/g); 95.2% had <10(2) fungi/g (mean 4.92 cfu/g).
- Arabic gum and tragacanth gum exhibited the highest bacterial and fungal contamination, respectively.
- Pregelatinized starch, cellulose, and lactose were the least contaminated excipients.
- Enterobacter, Serratia, and Proteus were isolated from 10 samples; no E. coli or Salmonella-Shigella detected.
- Only 5 samples failed to meet European Pharmacopoeia and USP microbiological standards.
Conclusions:
- Most pharmaceutical excipients analyzed comply with microbiological standards.
- Arabic gum and tragacanth gum require careful monitoring due to higher contamination risks.
- The presence of opportunistic pathogens like Enterobacter, Serratia, and Proteus underscores the need for stringent quality control in excipient manufacturing.