High purity Levonorgestrel Progesterone Hormones CAS6533-00-2 Norgestrel
CAS: 6533-00-2
Formula: C21H28O2
Molecular Weight: 312.45
Synonyms: 13-Ethyl-17A-ethynyl-17b-hydroxy-4-gonen-3-one; DL-Norgestrel; Methylnorethindrone; A-Norgestrel;
EINECS: 229-433-5
Density: 1.139 g/cm3
Melting Point: 239-241 ° C(lit. )
Boiling Point: 459.139 ° C at 760 mmHg
Flash Point: 195.446 ° C
Appearance: White solid
Purity: 99%
Standard: USP32
Package: 1kg/foil bag or according to the customers requirement.
Storage: Room temperature
Usage Progestogen; oral contraceptive. The bioactive enantiomer is levorotatory ,A metabolite of Norgestrel.
Description:
Levonorgestrel (or l-norgestrel or D-norgestrel) (Plan B, Next Choice, Postinor, "the morning after pill," and others) 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.
It is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basichealth system.
Usage & Dosing:
(1) Oral contraception:
At low doses, levonorgestrel is used in monophasicand triphasicformulati*** of combined oral contraceptive pills, with ***ailable monophasic doses ranging from 100-250μg, and triphasic doses of 50μg/75μg/125μg.
At very low daily dose of 30μg, levonorgestrel is used in some progestogen only pillformulati***.
(2) Emergency contraception:
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 mechani*** 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 is also used in Intrauterine system, Contraceptive implants and Hormone replacement therapy.
COA:
Items Specification Results
Description White or practically white crystalline powder White crystalline powder
Specific Rotation 30¡ã~-35¡ã 32¡ã
Melting Range 232~239¡ãC, and melting range is not more then 4¡ãC 234~238¡ãC
identification It complies with the test for specific optical rotation and melting point Conforms
Infrared absorption spectrophotometry should be c***istent with levonorgestrel CRS Conforms
Loss on drying ¡Ü0.5% 0.20%
Residue on ignition ¡Ü0.3% 0.07%
Limit of Ethynyl Group 7.81%~8.18% 7.92%
Related substances Single impurity ¡Ü0.5% single impurity<0.5%
Total Impurities ¡Ü2.0% Total impurities<2.0%
Organic Volatile impurties Ethanol ¡Ü5000ppm 1200ppm
Assay The product complies with specification in USP34
Particle Size D(0.9)<10¦&Igr***e;m
Storage Condition Sealed, protect from light
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