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| Analytical Attribute | Technical Standard / Specification | Validation Methodology |
|---|---|---|
| CAS Registry Number | 1424-00-6 (Mesterolone Reference Standard) | CAS Verification & SciFinder Cross-Check |
| Molecular Formula & Weight | C20H32O2 | 304.47 g/mol | High-Resolution Mass Spectrometry (HRMS) |
| Chemical Name / IUPAC | 1α-methyl-5α-androstan-17β-ol-3-one | 1H-NMR & 13C-NMR Spectroscopy |
| Assay Purity (HPLC) | ≥ 98.5% to ≥ 99.2% (Grade-Specific) | Reversed-Phase High-Performance Liquid Chromatography |
| Physical Appearance | White to almost white crystalline powder | Visual & Optical Microscopy Comparison |
| Melting Point Range | 207 °C – 211 °C | Capillary Differential Thermal Analysis (DTA) |
| Loss on Drying (LOD) | ≤ 0.5% max | Gravimetric Drying (105°C, 3 hours) |
| Heavy Metals & Elemental Impurities | ≤ 10 ppm (As, Pb, Cd, Hg within ICH Q3D limits) | Inductively Coupled Plasma Mass Spectrometry (ICP-MS) |
| Residual Solvents | Class 2 & Class 3 within ICH Q3C limits | Headspace Gas Chromatography (HS-GC-FID) |
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