PE 22-28

✓ Sterility — validated by multiple complementary methods Dual-method

Each lot is screened using methods with different strengths: the traditional pharmacopeia standard for regulatory rigor, plus rapid-detection methods that catch viable cells the classical method can miss. All methods must pass before a lot ships.

USP Vanguard Laboratory Result: Pass. ScanRDI Eagle Analytical Services Inc. No Method Suitability on file. Date Started: 2025-10-30, Date Completed: 2025-11-02. Submission #: ETX-251028-0586 Result: Pass. (size: 10mg)