Test Analysis Standard Results
Characteristics White to yellowish-white crystalline powder conform
Assay 97 ~ 103% 99.31%
Loss on drying ≤0.5% 0.18%
Identification Positive conform
Specific optical rotation ﹢77°~﹢82° +79.3°
Melting point 32 ~ 37℃ 34~36℃
Free heptanoic acid ≤0.2% 0.11%
Related substances ≤2% conform
Residual solvents(GC) ≤100ppm conform
Conclusion This batch is complies with EP 5