primogyn c(or m)
Ethinylestradiol
CAS: 57-63-6
Molecular Formula: C20H24O2
primogyn c(or m) - Names and Identifiers
primogyn c(or m) - Physico-chemical Properties
| Molecular Formula | C20H24O2 |
| Molar Mass | 296.4 |
| Density | 1.21g/cm3 |
| Melting Point | 182-183℃ |
| Boling Point | 457.2°C at 760 mmHg |
| Specific Rotation(α) | -30 ° (C=0.4, Pyridine) |
| Flash Point | 211.2°C |
| Solubility | DMSO 59 mg/mL;Water <1 mg/mL;Ethanol 59 mg/mL. Soluble in ethanol, propanol, ether, chloroform, dioxane, vegetable oil and sodium hydroxide solution, almost insoluble in water. |
| Vapor Presure | 3.74E-09mmHg at 25°C |
| Appearance | White to milky white crystalline powder |
| Storage Condition | -20℃ |
| Sensitive | Sensitive to light |
| Refractive Index | 1.623 |
| MDL | MFCD00003690 |
| Physical and Chemical Properties | Melting Point: 142 - 146 water-soluble:<0.1g/100 mL at 21 C Appearance: pure white to milky white powder |
| Use | Belonging to estrogens |
primogyn c(or m) - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | R45 - May cause cancer R22 - Harmful if swallowed |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
primogyn c(or m) - Reference
| Reference Show more | Sha haolei, Zhang Zhiyan, Xia Jingfen, et al. Detection and risk assessment of typical environmental estrogens in Dongqian Lake, Ningbo [J]. Sichuan environment, 2015, 34(06):10-14. |
primogyn c(or m) - Standard
Authoritative Data Verified Data
This product is 3-hydroxy-19-nor-17a-pregnane-1, 3,5(10)-trien-20-acetyl-17-OL. The content of C20H2402 shall be 97.0% ~ 103.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
primogyn c(or m) - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is soluble in ethanol, propanol or ether, soluble in chloroform, insoluble in water.
melting point
The melting point of this product (General 0612) is 180~186°C.
specific rotation
take this product, precision weighing, and pyridine dissolved and quantitative dilution of solution containing about 10 mg per 1 ml, according to the law (General 0621), the specific rotation is from one to 26 ° to one to 31 °.
Last Update：2022-01-01 13:37:32
primogyn c(or m) - Differential diagnosis
Authoritative Data Verified Data
- After 2mg of this product is taken and dissolved with sulfuric acid, the solution shows orange-red color and yellow-green fluorescence appears under the reflected light line. Pour the solution into 4ml of human water to form a rose-red flocculent precipitate.
- Take 10mg of this product, add 1 ml of ethanol to dissolve, add 5-6 drops of silver nitrate test solution to generate white precipitate.
- 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 259).
Last Update：2022-01-01 13:37:33
primogyn c(or m) - Exam
Authoritative Data Verified Data
Related substances
take the test solution under the content determination item as the test solution; Take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, and shake it well, as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are accurately weighed and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 2.5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the area of the main peak of the control solution..
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
Last Update：2022-01-01 13:37:33
primogyn c(or m) - 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; Acetonitrile-water (45:55) was used as the mobile phase; The detection wavelength was 280nm. Take 10mg of estradiol control substance, put it in 50ml measuring flask, add 10ml of test solution, dilute it to scale with mobile phase, take lml, put it in 10ml measuring flask, dilute it to scale with mobile phase, shake well, 20u1 was injected into human liquid chromatograph, and the chromatogram was recorded. The theoretical plate number is not less than 1000 according to the ethinyl estradiol peak, and the separation degree of estradiol peak and ethinyl estradiol peak should be greater than 3.5.
assay
take this product, precision weighing, add mobile phase dissolution and quantitative dilution to make a solution containing about 1 mg per 1 ml, as a test solution, precision volume 20u1 injection of human liquid chromatography, the chromatogram was recorded; Another reference substance of ethinyl estradiol was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:37:34
primogyn c(or m) - Category
Authoritative Data Verified Data
estrogen drugs.
Last Update：2022-01-01 13:37:34
primogyn c(or m) - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:37:34
primogyn c(or m) - Ethinylestradiol tablets
Authoritative Data Verified Data
This product contains ethinyl estradiol (C20H2402) should be 90.0% to 110.0% of the label.
trait
This product is sugar-coated tablets, remove the coating, white or white.
identification
- take an appropriate amount of fine powder of this product (about 20ug of ethinylestradiol), add 5ml of anhydrous ethanol, grind for several minutes, filter, evaporate the filtrate in a water bath, and add 1ml of sulfuric acid Dropwise to the residue, it is orange-red.
- 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.
examination
- Content uniformity: Take 1 tablet of this product, place it in a packed test tube (5ug specification, 20ug specification and 50ug specification) or a 100ml measuring flask (500ug specification), and add mobile phase lml(5ug specification) accurately. Or 4ml ( 20ug specification) or 10ml(50ug specification) or appropriate amount (500ug specification), ultrasonic to dissolve ethinyl estradiol, cool, the latter is diluted with mobile phase to the scale, shake, centrifuge * Take the supernatant to determine the content according to the method under the content determination item, the limit is 20%, and it should comply with the regulations (General 0941).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- color introduction conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water (70:30) as mobile phase; The detection wavelength was 220mn. The number of theoretical plates shall not be less than 2000 calculated by ethinyl estradiol peak, and the separation degree between ethinyl estradiol peak and adjacent peaks shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about 50ug equivalent to ethinylestradiol), set the test tube, Precision Plus mobile phase 10ml, ultrasonic dissolution of ethinyl estradiol, shake, cool, centrifuge, take the supernatant as test solution, take 20u1 injection of human liquid chromatography with precision, record chromatogram; Take ethinyl estradiol reference substance, precision weighing, adding mobile phase dissolution and quantitative dilution to make a solution containing about 5ug per lml, determined by the same method, calculated by peak area according to external standard method.
category
isoethinyl estradiol.
specification
(1)5ug(2)20ug(3)50ug (4)500ug
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:37:35
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View History
primogyn c(or m)
Diphenylethinylcarbinol
聚异丁烯(PIB)
反-1,3-戊烯
a-溴乙酸甲酯
益收宝粉剂
(3Z)-4-methoxybut-3-en-2-one
METHYLTHIOMETHYLMERCAPTAN
Methyl(triphenylsilyl) ether
Diphenylethinylcarbinol
聚异丁烯(PIB)
反-1,3-戊烯
a-溴乙酸甲酯
益收宝粉剂
(3Z)-4-methoxybut-3-en-2-one
METHYLTHIOMETHYLMERCAPTAN
Methyl(triphenylsilyl) ether