TABLE I

USP QC Microorganism Requirements for Method Suitability and Growth Promotion Testing

Microorganism ClassificationCompendial QC StrainsUSP <60>USP <61>USP <62>USP <71>
Gram-positive cocciStaphylococcus aureusYesYesYesYes
Micrococcus luteusNoNoNoYes
Gram-positive, spore-forming rodsBacillus subtilisNoYesNoYes
Gram-negative, oxidase-positive rodsPseudomonas aeruginosaYesYesYesYes
Burkholderia cepacia ComplexYesNoNoNo
Gram-positive, anaerobic bacteriaClostridium sporogenes (spore former)NoNoYesYes
Bacteroides vulgatus (non-spore former)NoNoNoYes
Gram-negative, fermentative rodsEscherichia coliNoYesYesNo
Salmonella enterica serovar typhimuriumNoNoYesNo
YeastCandida albicansNoYesYesYes
Filamentous fungiAspergillus brasiliensisNoYesNoYes
  • Abbreviations: QC, quality control; USP, U.S. Pharmacopeia.