Name:Levonorgestrel
Synonyms:D(-)-13beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one
Molecular Formula:C21H28O2
Molecular Weight:312.45
CAS Number:797-63-7
EINECS:212-349-8
Levonorgestrel is a medicine which is used in emergency hormonal contraception. Levonorgestrel is a hormone which is similar to the hormoneprogesterone that is produced by the body. It is used as emergency contraception to prevent a pregnancy after unprotected sex or after failure of a contraceptive method. It is thought to work by preventing the release of eggs from the ovary and preventing the sperm from penetrating an egg. It may also change the lining of the uterus which makes it difficult for an egg to develop.
| Items | Specification | Results |
| Description | White or practically white crystalline powder | White crystalline powder |
| Specific Rotation | 30°~-35° | 32° |
| Melting Range | 232~239°C, and melting range is not more then 4°C | 234~238°C |
| identification | It complies with the test for specific optical rotation and melting point | Conforms |
| Infrared absorption spectrophotometry should be consistent with levonorgestrel CRS | Conforms | |
| Loss on drying | ≤0.5% | 0.20% |
| Residue on ignition | ≤0.3% | 0.07% |
| Limit of Ethynyl Group | 7.81%~8.18% | 7.92% |
| Related substances | Single impurity ≤0.5% | single impurity<0.5% |
| Total Impurities ≤2.0% | Total impurities<2.0% | |
| Organic Volatile impurties | Ethanol ≤5000ppm | 1200ppm |
| Assay | The product complies with specification in USP34 | |
| Particle Size | D(0.9)<10μm | |
| Storage Condition | Sealed, protect from light | |
