USP<61>
Contact UsGeneral Chapter USP<61>
The General Chapter USP<61> covers testing for pharmaceutical products to determine antimicrobial activities. The objective of the Growth Promotion Test is to demonstrate the media used to enumerate the microorganisms is suitable.
Media Growth Promotion Testing
The media Growth Promotion Test (GPT) is performed by inoculating new batches of media with a small number of microorganisms and compare with prior tested or approved media batches. Evaluating media that is used for USP<797> via GPT adds another layer of controls to ensure the highest quality of USP testing services.
Performance Parameters for Media Testing:
| Media Type | Microorganisms | Incubation Temp | Incubation Time |
| Soybean Casein Digest Agar or Broth (TSA or TSB) | Staphylococcus aureus | 30 - 35°C | ≤ 72 hours |
| Pseudomonas aeruginosa | 30 - 35°C | ≤ 72 hours | |
| Bacillus subtilis | 30 - 35°C | ≤ 72 hours | |
| Candida albicans | 30 - 35°C | ≤ 72 hours | |
| Aspergillus niger | 30 - 35°C | ≤ 72 hours | |
| Sarbouraud Dextrose Agar or Broth (SDA, SDB), Potato Dextrose Agar (PDA), Malt Extract Agar (MEA) | Candida albicans | 20 - 25°C | ≤ 120 hours |
| Aspergillus niger | 20 - 25°C | ≤ 120 hours |
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