ABSTRACT

Tests for the detection of four named bacteria (Escherichia coli, salmonellae, Pseudomonas aeruginosa and Staphylococcus aureus) in pharmaceutical raw materials and finished products are described in the United States Pharmacopoeia (USP) (1995), and in the European Pharmacopoeia (EP) (1997) and British Pharmacopoeia (BP) (1999) (where the tests are identical). The EP and BP additionally describe a test for the detection of Clostridium perfringens. These organisms are singled out for special attention in this way because they represent particular infection hazards to the patient, or because their presence is a criterion of the quality of raw materials.