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| Parameter | Method | Acceptance Limit (Extra Quality) | Result for V05 | |-----------|--------|----------------------------------|----------------| | Appearance | Visual | White to off-white powder | [Compliant] | | Identification (IR, HPLC RT) | USP <197> | Match reference spectrum | Pass | | Assay (anhydrous basis) | HPLC (area %) | 99.5 – 100.5% | 99.82% | | Total related substances | HPLC | ≤0.3% | 0.12% | | Single largest impurity | HPLC | ≤0.10% | 0.04% | | Residual solvents (Class 2) | GC headspace | ≤ ICH limit | Below LOQ | | Water content (KF) | Karl Fischer | ≤0.5% | 0.21% | | Particle size (D90) | Laser diffraction | ≤20 µm (if solid) | 15.3 µm | Too clear

The voice was clear. Too clear. It sounded as if the speaker was standing directly behind Elias’s left shoulder. Elias spun around, his heart hammering. The room was empty.

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Elias reached for the stop button, but his hand froze.