Levonorgestrel

General Information

Levonorgestrel Impurities and Levonorgestrel

Daicel Pharma offers superior-quality Levonorgestrel impurities, such as Levonorgestrel EP impurity A. These impurities are vital for evaluating Levonorgestrel quality, stability, and biological safety. Further, Daicel Pharma excels in the custom synthesis of Levonorgestrel impurities and ensures their global delivery.

Levonorgestre [CAS: 797-63-7] is approved by the World Health Organization and the US FDA as an emergency contraceptive drug. It is a synthetic progestogen and a 19-nortestosterone derivative. It is effective when taken in the pre-ovulation stage and helps control menstrual disorders.

Levonorgestrel: Use and Commercial Availability  

Levonorgestrel is an emergency oral contraceptive pill. It prevents pregnancy and is an off-counter drug. It is used within 72 hours of unprotected sexual intercourse or due to contraceptive failure. It combines with estradiol as an oral pill for birth control. Levonorgestrel is available as implants, transdermal patches, and oral formulations. Levonorgestrel intrauterine device (IUD)is effective in treating adenomyosis. Skyla, Mirena, Liletta, Kyleena, and Jadelle are some Levonorgestrel brand names. Many brands of Levonorgestrel are available in the market.

Levonorgestrel Structure and Mechanism of Action

The chemical name of Levonorgestrel is 13-Ethyl-17-ethynyl-17β-hydroxy-4-gonen-3-one. The chemical formula for Levonorgestrel is C₂₁H₂₈O₂, and its molecular weight is approximately 312.45 g/mol.

Levonorgestrel binds to androgen and progesterone receptors, causing the delay of gonadotropin-releasing hormone. It prevents the luteinizing hormone surge during the pre-ovulation stage. Further, it stops ovulation by blocking follicular rupture and prevents fertilization. It delays the release of a viable egg from the ovaries. It interferes with sperm motility and passage by thickening the cervical mucus.

Levonorgestrel Impurities and Synthesis

When synthesizing Levonorgestrel1, the formation of impurities may affect drug safety and efficacy. They form during the synthetic process, storage, or purification of Levonorgestrel. Levonorgestrel impurities need to have continuous control and monitoring to ensure that the drug is safe, effective, and stable.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Levonorgestrel impurities, which includes Levonorgestrel EP impurity A. The CoA is from a cGMP-compliant analytical facility and consists of the complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Levonorgestrel impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Levonorgestrel. A complete characterization report accompanies the Levonorgestrel impurity delivery.