39791-20-3 - Names and Identifiers
Name | Nilestriol
|
Synonyms | 39791-20-3 NILESTRIOL nylestriol Nilestriol 17α-Ethynyl-3-cyclopentyloxyestra-1,3,5(10)-triene-16α,17β-diol 17a-Ethynylestra-1,3,5(10)-triene-3,16a,17b-triol 3-Cyclopentyl Ether (16a,17b)-3-(Cyclopentyloxy)-17-ethynylestra-1,3,5(10)-triene-16,17-diol 3-(cyclopentyloxy)-17alpha-ethinyl-1,3,5(10)-estratrien-16alpha,17beta-diol (16alpha,17beta)-3-(cyclopentyloxy)-17-ethynylestra-1,3,5(10)-triene-16,17-diol (16alpha,17beta)-3-(Cyclopentyloxy)-17-ethynylestra-1(10),2,4-triene-16,17-diol 17alpha-ethynylestra-1,3,5(10)-triene-3,16alpha,17beta-triol 3-cyclopentyl ether 17alpha-Ethynylestra-1,3,5(10)-triene-3,16alpha,17beta-triol 3-cyclopentyl ether 3-cyclopentyloxy-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-16,17-diol (8R,9S,13S,14S,16R,17R)-3-cyclopentyloxy-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-16,17-diol (8R,9S,13S,14S,16R,17R)-3-(cyclopentoxy)-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-16,17-diol
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CAS | 39791-20-3
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InChI | InChI=1/C25H32O3/c1-3-25(27)23(26)15-22-21-10-8-16-14-18(28-17-6-4-5-7-17)9-11-19(16)20(21)12-13-24(22,25)2/h1,9,11,14,17,20-23,26-27H,4-8,10,12-13,15H2,2H3/t20-,21-,22+,23-,24+,25+/m1/s1 |
39791-20-3 - Physico-chemical Properties
Molecular Formula | C25H32O3
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Molar Mass | 380.52 |
Density | 1.21±0.1 g/cm3(Predicted) |
Melting Point | 162-165 °C(Solv: ethyl ether (60-29-7); hexane (110-54-3)) |
Boling Point | 521.7±50.0 °C(Predicted) |
Flash Point | 269.3°C |
Vapor Presure | 1.03E-11mmHg at 25°C |
pKa | 12.57±0.60(Predicted) |
Storage Condition | RT, dark |
Refractive Index | 1.611 |
Use | Estrogens for the treatment of menopausal syndrome caused by estrogen deficiency |
39791-20-3 - Standard
Authoritative Data Verified Data
This product is 3-(cyclopentyloxy)-19-nor-17-pregnane-1, 3,5(10)-trien-20-alkyn-16a, 17a-diol. Based on the dry product, the content of C25H3203 should be 97.0% ~ 103.0%.
Last Update:2024-01-02 23:10:35
39791-20-3 - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder.
- This product is soluble in chloroform, soluble in acetone, slightly soluble in ethanol, almost insoluble in water.
melting point
The melting point of this product (General 0612) is 160~165°C.
specific rotation
take this product, precision weighing, plus absolute ethanol dissolution and quantitative dilution of about 10 mg per lml solution, according to the law (General 0621), the specific rotation is 2 ° to 10 °.
Last Update:2022-01-01 11:42:22
39791-20-3 - Differential diagnosis
Authoritative Data Verified Data
- take this product and add 2-3 drops of sulfuric acid to show Rose Red. Pour this solution into 5ml of water to show blue-purple color.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 136).
Last Update:2022-01-01 11:42:22
39791-20-3 - Exam
Authoritative Data Verified Data
Related substances
take this product, add chloroform-methanol (9:1) to dissolve and dilute to prepare a solution containing about 10 mg per lml as a test solution; Take lml with precision, in a 50ml measuring flask, dilute to the mark with trimethyl methane-methanol (9:1) and shake to a control solution. According to the thin layer chromatography (General 0502) test, absorb 5 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with benzene-acetone (4:1) as the developing solvent, it was developed, dried, sprayed with sulfuric acid-ethanol (4:1), heated at 105 ° C. For 20 minutes, and examined under a UV lamp (365mn). If the test solution shows impurity spots, the color should not be deeper compared with the main spots of the control solution.
loss on drying
take this product and dry under reduced pressure at 80°C for 4 hours, and the weight loss shall not exceed 3.0% (General rule 0831).
Last Update:2022-01-01 11:42:23
39791-20-3 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-water (80:20) was used as the mobile phase; The detection wavelength was 221nm. The theoretical plate number is not less than 2500 as calculated by the nylestriol peak.
assay
take this product, precision weighing, plus mobile phase dissolution and quantitative dilution made from each 1ml containing about 0.lmg solution, as a test solution, the precision of 20u1 injection of human liquid chromatography, recording chromatogram; Another nylestriol reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update:2022-01-01 11:42:24
39791-20-3 - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:42:24
39791-20-3 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 11:42:24
39791-20-3 - Nilestriol tablets
Authoritative Data Verified Data
This product contains nilestriol (C25H3203) should be 90.0% to 110.0% of the label.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 20mg equivalent to neichenate), add chloroform 30ml to extract, filter, and heat on a water bath to remove chloroform, the residue showed the same reaction according to the Identification Test (1) under the item of nylestriol.
- The filtrate obtained under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the absorption maximum was found at wavelengths of NM and Nm.
examination
- Content uniformity: Take 1 tablet of this product, add an appropriate amount of anhydrous ethanol, sonicate for about 10 minutes to dissolve nilestriol, let it cool, and quantitatively dilute it with anhydrous ethanol to make it contain about nilestriol 0 per 1 ml. lmg solution, shake, filter, take the filtrate * according to the content determination method under the item, should comply with the provisions (General 0941).
- dissolution: according to the dissolution and release determination method (General rule 0931 method), 0.5% sodium dodecyl sulfate solution is used as the dissolution medium, and the rotation speed is 50 rpm, after 60 minutes, 10ml of the solution was taken, filtered, and the appropriate amount of the filtrate was taken and quantitatively diluted with the dissolution medium to prepare a solution containing about 6.5ug of nilestriol per 1 ml as a test solution; separately, the neiche female fermentation control product was precision weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 6.5ug per 1 ml, which was used as the control solution. According to the chromatographic conditions under the item of determination of nylestriol content, 50 u1 of the test solution and 50 u1 of the reference solution were accurately measured, and human liquid chromatograph was injected respectively to record the chromatogram, the dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
- others should be in accordance with the relevant provisions under the item of tablets (General rule OlOl).
determination of content
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 10mg equivalent to nilestriol), put it in a 100ml measuring flask, add an appropriate amount of anhydrous ethanol, heat in a hot water bath for 30 minutes, continuously shake to dissolve nylestriol, let it cool, dilute with anhydrous ethanol to the scale, shake well, filter, and add filtrate, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 280nm; Another nylestriol reference substance was determined by the same method and calculated.
category
with nilestriol.
specification
(l)lmg (2)2mg (3)5mg
storage
sealed and stored in a dry place.
Last Update:2022-01-01 11:42:25