品名 左炔诺孕酮 数量

Product Name Levonorgestrel Batch Size 100g

检验依据 美国药典 32版 包装

Reference Standard USP 32 Packing

检验项目 质量标准 检验结果

TEST ACCEPTANCECRITERIONS

RESULTS 正性反应

鉴别 TLC Positive

Identification UV spectrum Positive

R spectrum Positive

**istics White or yellowishcrystallineowder conform

Melting point 232 ~ 239℃

Loss on drying ≤0.5%

** rotation –30~ –35°

Limit of ethinyl group 7.81~8.18%

Residual Solvents ethanol≤0.5% Pass

其它甾体 sum of the impurities≤2.0% 合格

Other sterold single impurity ≤0.5% Pass

Residue on ignition ≤0.3%

Assay 98.0~102.0%

Conclusion This batch complies with USP 38

Supervisor 张慧 Analyst zhanghui