Comprehensive purity evaluation of DROSTANOLONE-P using validated analytical methods.
HPLC,GC-MS
| Parameter | Value |
|---|---|
| Sample Identification | DROSTANOLONE-P (Lote# DRP822-2024) |
| Concentration | 1.95 mg/mL ± 0.08 |
| Purity | 98.7% |
| Impurities | <1.3% |
HPLC analysis showed excellent chromatographic performance with resolution >3.2 between the main peak and closest eluting impurity. GC-MS confirmed the molecular structure with characteristic fragmentation pattern. Related substances analysis detected only minor impurities well below identification thresholds. Forced degradation studies showed the product is stable under thermal conditions but susceptible to oxidation.
DROSTANOLONE-P demonstrates high purity and stability characteristics meeting all requirements.