Levonorgestrel CAS 797-63-7
01 Overview
Levonorgestrel is used in emergency contraceptive pills(ECPs), both in a combined Yuzpe regimenwhich includes estrogen, and as a levonorgestrel-only method. The levonorgestrel-only method uses levonorgestrel 1.5mg (as a single dose or as two 0.75mg doses 12 hours apart) taken within 3 days of unprotected sex, with one study indicating that beginning as late as 120 hours (5 days) after intercourse could be effective.
02 Details
Pure 99% Levonorgestrel Estrogen powder Progestogens raw materials white powder
Product Description
Levonorgestrel
English Synonyms: 13-ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one; 13-ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one; 13-ethyl-17-hydroxy-19-dinor-17-alpha-pregn-4-en-20-yn-3-on(+)-1; 17-alpha-ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one; 17-beta-hydroxy-18-methyl-19-nor-17-alpha-pregn-4-en-20-yn-3-one; 17-ethynyl-18-methyl-19-nortestosteron; 17-ethynyl-18-methyl-19-nortestosterone; 18-methyl-17-alpha-ethynyl-19-nortestosterone
CAS NO.: 797-63-7
Assay: 99%
Molecular Formula: C21H28O2
Molecular Weight: 312.45
Quality Standard: USP
Packing: 1kg/foil bag/tin
Appearance: White or almost white crystalline powder
Usage: Progesterone drug, used for irregular menstruation, functional uterine bleeding, endometriosis, etc
Levonorgestrel Usage:
Levonorgestrel is used in emergency contraceptive pills(ECPs), both in a combined Yuzpe regimenwhich includes estrogen, and as a levonorgestrel-only method. The levonorgestrel-only method uses levonorgestrel 1.5mg (as a single dose or as two 0.75mg doses 12 hours apart) taken within 3 days of unprotected sex, with one study indicating that beginning as late as 120 hours (5 days) after intercourse could be effective.
The primary mechanism of action of levonorgestrel as a progestogen-only emergency contraceptive pill is, according to FIGO, to prevent fertilization by inhibition of ovulation. The International Federation of Gynecology and Obstetrics(FIGO) has issued a statement that: “review of the evidence suggests that LNG [levonorgestreol] ECPs cannot prevent implantation of a fertilized egg. Language on implantation should not be included in LNG ECP product labeling.” In June 2012, a New York Timeseditorial called on the Food and Drug Administration(FDA) to remove from the label the unsupported suggestion that levonorgestrel emergency contraceptive pills inhibit implantation. In November 2013, the European Medicines Agency(EMA) approved a change to the label for HRA Pharma’s NorLevo saying it cannot prevent implantation of a fertilized egg. In November 2013, the EMA also approved a change to the label for HRA Pharma’s NorLevo saying: “In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg [165 pounds] or more, and levonorgestrel was not effective in women who weighed more than 80 kg [176 pounds].” In November 2013 and January 2014, the FDA and the EMA said they were reviewing whether increased weight and body mass index(BMI) reduce the efficacy of emergency contraceptives.
Levonorgestrel Powder Description:
Levonorgestrel (or l-norgestrel or D-norgestrel) is a second generation progestin (synthetic progestogen) used as an active ingredient in some hormonal contraceptives, includingcombined oral contraceptive pills, progestogen only pills, emergency contraceptive pills, intrauterine systems, contraceptive implants, and hormone replacement therapy.
Levonorgestrel is used in emergency contraceptive pills(ECPs), both in a combined Yuzpe regimenwhich includes estrogen, and as a levonorgestrel-only method. The levonorgestrel-only method uses levonorgestrel 1.5mg (as a single dose or as two 0.75mg doses 12 hours apart) taken within 3 days of unprotected sex, with one study indicating that beginning as late as 120 hours (5 days) after intercourse could be effective.
Levonorgestrel Powder Applications:
1. Oral contraception:
At low doses, levonorgestrel is used in monophasic and triphasic formulations of combined oral contraceptive pills, Levonorgestrel is used for promoting the synthesis of protein and reduce the decomposition of amino acid, and for improving muscle hyperplasia, action and enhance male sexual characteristics.
2. Emergency contraception:
Levonorgestrel is used in emergency contraceptive pills (ECPs), both in a combined Yuzpe regimen which includes estrogen, and as a levonorgestrel-only method. The levonorgestrel-only method uses levonorgestrel 1.5 mg (as a single dose or as two 0.75 mg doses 12 hours apart) taken within 3 days of unprotected sex, with one study indicating that beginning as late as 120 hours (5 days) after intercourse could be effective.
3. Intrauterine system:
Levonorgestrel is the active ingredient in the Mirena & Skyla (Jaydess) intrauterine system.The levonorgestrel-only method uses levonorgestrel 1.5mg (as a single dose or as two 0.75mg doses 12 hours apart) taken within 3 days of unprotected sex, with one study indicating that beginning as late as 120 hours (5 days) after intercourse could be effective.
4. Contraceptive implants
Levonorgestrel is the active ingredient in Norplant and Jadelle.
5. Hormone replacement therapy
Levenorgestrel is combined with 17-beta estradiol in the Climara Pro hormonal patch.
Levonorgestrel Specification:
| 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 | |
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