Orforglipron Impurity 52

China [CN]

Molecular Formula (Derived): C₂₉ - C₃₁H₂₆ - ₂₈F₂N₈O (Compared to the final intermediate, the number of C and H atoms may be reduced by 1-3 and 2-4 respectively due to side reactions, while the number of heteroatoms remains essentially unchanged.)

Molecular Weight (Derived): 534-562 (Slight variations depending on the specific defect structure)

Core Uses: 1. Quality control of Oglufanib API: Used as an HPLC impurity reference standard for limit testing (usually ≤0.1%); 2. Drug impurity profile research: Supports ICH Q3A/B compliance filing; 3. Process optimization: Locates side reaction sites during synthesis to improve API purity.

Key Physicochemical Properties (Derived): 1. Appearance: White to off-white crystalline powder; 2. Solubility: Slightly soluble in water, readily soluble in DMSO and DMF, soluble in dichloromethane; 3. Stability: Stable under vacuum and protected from light at room temperature, avoid strong acids, strong bases, and high temperatures (degrades easily at ≥80℃); 4. Chirality: If a (4S) chiral center is present, the ee value needs to be controlled at ≥99.0% (chiral purity of the impurity itself).