Product Details
Product Details
Proficiency Test for laboratories testing pharmaceutical materials for the presence or absence of specified microorganisms in accordance with USP 71. A five vial sample panel with three POSITIVE (non-sterile) and two NEGATIVE (sterile) containing organisms of interest at appropriate levels for USP <71>. The panel contains five single-pellet vials, three positive sample pellets containing Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, or Aspergillus brasiliensis. as well as Two blank pellets. The panel also includes five 5mL vials of sterile peptone buffer. Participants will identify which samples meet the sterility test requirements per the USP monograph.
USP PT Schedule
USP PT Schedule
| Study Number | Study Open Date | Study Close Date |
| PH-0422 | 4/18/2022 | 07/15/2022*
Extended from 6/9/22 |
| PH-0922 | 9/19/2022 | 11/18/2022 |
| PH-0123 | 1/16/2023 | 3/17/2023 |
| PH-0523 | 5/15/2023 | 6/14/2023 |
MSDS/SDS
MSDS/SDS
USP Harmonized Compendial Methods
USP Harmonized Compendial Methods
| United States Pharmacopeia (USP) | Ph. Eur, EP | JP | NSI Catalog Item | Harmonized Description |
|
USP <61> |
<2.6.12> |
JP <35> Microbial Limit Test |
PHPT-022 |
Microbial Enumeration of Non-sterile Products |
|
USP <62> Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms |
<2.6.13> |
JP <35> Microbial Limit Test |
PHPT-015 |
Test for Specified Microorganisms in Non-sterile Products |
|
USP <71> Sterility Testing |
<2.6.1> |
JP <4.06> |
PHPT-021 |
Sterility Test |
|
USP <51> Antimicrobial Effectiveness Testing |
<5.1.3> |
JP <19> |
PHPT-024 |
Preservative Efficacy Test |
