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Lot 4521 · Stability Q1 2h

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eln.lablynx.app / experiments / exp.4521.stab-q1

Experiments › Lot 4521 · Stability Q1

Running

Sample LOT-4521 · Protocol STAB-Q1 · Operator J. Martinez · Day 14 / 90 · Started 2026-04-08

Objectives

Verify Lot 4521 meets ICH Q1A long-term stability through 90 days at 25°C / 60% RH.

Readings · timepoint data

Day Assay Impurities Dissolution

0 99.8% 0.12% 97.4%

7 99.4% 0.18% 97.1%

14 99.2% 0.22% 96.8%

28 — — —

Chromatogram · Day 14 USP <621> ✓

Materials & reagents

Lot 4521 · API 25 mg

Acetonitrile · HPLC 2.5 L

USP Ibuprofen Std. L4-22

Agilent 1260 II HPLC-02

Mettler XPR BAL-3

Attachments

chroma_d14.tif 8.7 MB

stability_q1.xlsx 142 KB

STAB-Q1.pdf 312 KB