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Analytical Method Development Report
Compound: A1B2-C3 | Project: Project Phoenix | Status: In Review
1. Introduction
This report outlines the development of a new analytical method for the quantification of Compound A1B2-C3 in raw material. The objective was to develop a robust, accurate, and precise HPLC method suitable for quality control purposes.
2. Methodology
A reversed-phase high-performance liquid chromatography (HPLC) method was developed using an Agilent 1260 Infinity II system. A Phenomenex Luna C18 column (4.6 x 150 mm, 5 µm) was used with a mobile phase consisting of a gradient of acetonitrile and 0.1% formic acid in water.
3. Results & Discussion
The method demonstrated good linearity (R² > 0.999), accuracy, and precision across the tested range. Long-term stability results at 25°C/60%RH are summarized below. A notable degradation was observed at the 12-month timepoint.
| Timepoint | Result (Assay) | Specification | Status |
|---|---|---|---|
| T0 | 99.8% | >98.0% | Pass |
| T1 Month | 99.5% | >98.0% | Pass |
| T3 Months | 99.2% | >98.0% | Pass |
| T6 Months | 98.1% | >98.0% | Pass |
| T12 Months | 97.9% | >98.0% | Fail |
4. Conclusion
The developed HPLC method is suitable for its intended purpose of quantifying Compound A1B2-C3. Further investigation is required to understand the degradation product observed at 12 months before proceeding to full validation.