6533-00-2
Norgestrel
CAS: 6533-00-2
Molecular Formula: C21H28O2
6533-00-2 - Names and Identifiers
6533-00-2 - Physico-chemical Properties
| Molecular Formula | C21H28O2 |
| Molar Mass | 312.45 |
| Density | 1.0697 (rough estimate) |
| Melting Point | 239-241°C(lit.) |
| Boling Point | 392.36°C (rough estimate) |
| Flash Point | 195.446°C |
| Solubility | Chloroform (Slightly, Sonicated), Dichloromethane (Slightly), Methanol (Slightly |
| Vapor Presure | 0mmHg at 25°C |
| Appearance | neat |
| Color | Crystals from diethyl ether-hexane |
| pKa | 13.09±0.40(Predicted) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.4900 (estimate) |
| Use | Content determination |
6533-00-2 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R40 - Limited evidence of a carcinogenic effect |
| Safety Description | S22 - Do not breathe dust. S36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | JF8259000 |
| HS Code | 2937230000 |
| Toxicity | LD50 oral in rat: 5010mg/kg |
6533-00-2 - Reference
| Reference Show more | 1. [IF=7.514] Suo Decheng et al."Trace analysis of progesterone and 21 progestins in milk by ultra-performance liquid chromatography coupled with high-field quadrupole-orbitrap high-resolution mass spectrometry."Food Chem. 2021 Nov;361:130115 |
6533-00-2 - Standard
Authoritative Data Verified Data
This product is 13-ethylsandohydroxy-18, 19-dinor-17a-pregnancy g-4-en-20-alkyn-3-one. The content of C21H2802 should be 97.0% ~ 103.0%.
Last Update：2024-01-02 23:10:35
6533-00-2 - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is dissolved in chloroform, slightly soluble in methanol, insoluble in water.
melting point
The melting point of this product (General rule 0612) is 204~212°C, and the melting distance is within 5°C.
Last Update：2022-01-01 13:37:23
6533-00-2 - Differential diagnosis
Authoritative Data Verified Data
- 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 109).
Last Update：2022-01-01 13:37:24
6533-00-2 - Exam
Authoritative Data Verified Data
ethynyl
take about 0.2g of this product, weigh it accurately, put it in a 50ml beaker, add 20ml of tetrahydrofuran, stir to dissolve, Add 10ml of 5% silver nitrate solution, according to the potentiometric titration method (General 0701), the glass electrode is used as the indicator electrode, the saturated calomel electrode (potassium nitrate saturated solution in the sleeve) is used as the reference electrode, and the sodium hydroxide titration solution (0.lmol/L) titration. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 2.503mg of ethynyl. The ethynyl group should be 7.8% to 8.2%.
Related substances
take this product, add mobile phase to dissolve and dilute to prepare a solution containing about 75ug per lml as a test solution; Take 2ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, 20ul of each of the test solution and the control solution are accurately measured and injected into the liquid chromatograph respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (2.0%).
Last Update：2022-01-01 13:37:25
6533-00-2 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
with eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (70:30) as mobile phase; Detection wavelength 240nm theoretical plate number according to the norgestrol peak calculation is not less than 2000, the resolution between the peak of Norgestrel and the peak of internal standard substance should meet the requirements.
preparation of internal standard solution
megestrol acetate was taken, dissolved in acetonitrile and diluted to prepare a solution containing about 1 mg per 1 ml.
assay
take about 7.5mg of this product, weigh it accurately, put it in a 50ml measuring flask, dissolve it with the mobile phase, dilute it to the scale, and shake it well; 2ml of the solution and 2ml of the internal standard solution were accurately measured and mixed evenly. As the test solution, 20 ml was injected into the liquid chromatograph and the chromatogram was recorded. According to the internal standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:37:25
6533-00-2 - Category
Authoritative Data Verified Data
progesterone drugs.
Last Update：2022-01-01 13:37:26
6533-00-2 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:37:26
6533-00-2 - Norgestrel and Ethinyl Estradiol tablets
Authoritative Data Verified Data
This product contains norgestrel C21H2802 should be 90.0% ~ 115.0% of the label amount, containing ethinyl ether should be 94.0% ~ 115.0% of the label amount.
trait
This product is sugar-coated tablet or film-coated tablet, white or almost White after removing the coating.
identification
take 1 tablet of this product, grind, add chloroform 5ml, fully stir, filter, take the filtrate as the test solution; Take the other norgestrel and the reference substance of ethinyl estradiol, chloroform was added to dissolve and dilute to make a solution containing about 1 mg each of Norgestrel and Ethinyl estradiol per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 30 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with chloroform-methanol (9:1) as the developing solvent, it was developed, dried, sprayed with sulfuric acid-anhydrous ethanol (1:1), and heated at 105 ° C. To develop color. The position and color of the main spots of the two components shown in the test solution should be the same as the corresponding main spots of the control solution.
examination
- Content uniformity take 1 tablet of this product, according to the method under the content determination item, from the "50ml measuring bottle", according to the law, according to the internal standard method to calculate the content by Peak area, the provisions shall be met (General rule 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).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (80:20) as mobile phase; The detection wavelength was 220mn. The number of theoretical plates shall not be less than 3000 calculated as the peak of norgestrol, and the separation degree between each component peak and the peak of internal standard substance shall meet the requirements.
- preparation of internal standard solution progesterone caproate was taken, dissolved with acetonitrile and diluted to give a solution containing about 0.12mg per 1 ml.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 12mg equivalent to norgestrol), put it in a 50ml measuring flask, add an appropriate amount of mobile phase, dissolve norgestrel and norethinyl ether by ultrasound, let them cool, dilute to scale with mobile phase, shake well, filter, take 1ml of continued filtrate and 1ml of internal standard solution with precision, mix well, 20ul was injected into human liquid chromatograph, and the chromatogram was recorded. The reference substance of Norgestrel and Ethinyl estradiol was separately taken, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing 0.24mg of norgestrol and 60ug of norestrol per lml. Each lml of the solution and the internal standard solution were accurately measured, mixed well, and determined by the same method. According to the internal standard method to calculate the peak area, that is.
category
progesterone drugs.
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:37:27
6533-00-2 - Compound Norgestrel Tablets
Authoritative Data Verified Data
This product contains norgestrel (C21H2802) and ethinylestradiol (C20H2402) should be 90.0% to 115.0% of the label amount.
prescription
norgestrel 300Mg
Ethinylestradiol 30Mg
Made into 1000 tablets
trait
This product is sugar-coated tablet or film-coated tablet, white or almost White after removing the coating.
identification
Take 2 tablets of this product, ground fine, add chloroform 10ml, fully stirred, filtered, take the filtrate on a water bath and concentrate to about 0.5ml, as a test solution. An appropriate amount of the control substance of Norgestrel and the control substance of ethinyl estradiol were separately taken, dissolved and diluted with three gas methane to prepare a solution containing about 1.2mg of Norgestrel and 0.12mg of ethinyl estradiol per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, extract the test solution and the reference solution each 5 u1, respectively, on the same silica gel G thin layer plate, with three gas methane-methanol (9:1) as a developing solvent, it was developed, dried, sprayed with sulfuric acid-anhydrous ethanol (1:1), and heated at 105 ° C. To develop color. The position and color of the two component main spots displayed by the test solution should be the same as that of the reference solution.
examination
should be in accordance with the relevant provisions under The tablet item (General rule 0101).
Content determination
- determination by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (60:40) as mobile phase; The detection wavelength was 220nm. The number of theoretical plates shall not be less than 3000 calculated as the peak of norgestrol, and the separation degree between each component peak and the peak of internal standard substance shall meet the requirements.
- preparation of internal standard solution megestrol acetate was taken, dissolved with acetonitrile and diluted to prepare a solution containing about 1 mg per 1 ml.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 1.5mg equivalent to norgestrol), put it in a 10ml measuring flask, precision adding 1ml of internal standard solution, add appropriate amount of mobile phase, ultrasonic dissolve Norgestrel and Ethinyl estradiol, cool, dilute to scale with mobile phase, shake well, filter, and take continued filtrate as test solution, the chromatogram was recorded by 20ul injection into human liquid chromatograph, and the reference substance of norgestrol and ethinylestradiol was separately taken for precise weighing, add acetonitrile to dissolve and quantitatively dilute to make a solution containing 1.5mg of Norgestrel and 0.15mg of ethinyl estradiol per 1ml. Take 1ml of each solution and 1ml of internal standard solution for precise measurement and put it in a 10ml measuring flask, add mobile phase diluted to scale, shake, the same method. According to the internal standard method to calculate the peak area, that is.
category
birth control pills.
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:43:27
6533-00-2 - Compound norgestrol dropping pills
Authoritative Data Verified Data
This product contains norgestrel (C21H2602) and ethinylestradiol (C20H2402) should be 90.0% to 115.0% of the label amount.
prescription
norgestrel 300Mg
Estradiol 30Mg
Made of 1000 pills
trait
This product is sugar-coated pills.
identification
- take 1 pill of this product, remove the coating, add about 2ml ethanol, slightly warm to dissolve and let it cool, add basic trinitrophenol solution (take 0.6% trinitrophenol ethanol solution, 7% sodium hydroxide solution and dilute ethanol 10ml each, mixed immediately before use) 2ml, after standing for about 30 minutes, the solution was Brown yellow.
- take 1 pill of this product, remove the coating, put it in a small beaker, add about 4ml of water, slightly warm it to dissolve it, let it cool, move it to the separating funnel, add 20ml of ether, after washing with shaking water, the ether layer was filtered through a filter covered with cotton wool and anhydrous sodium sulfate, placed in an evaporation dish, and evaporated ether at low temperature on a water bath, 0.3ml of trichloromethane was added to dissolve as a test solution; Another control of norgestrol and ethinylestradiol was taken and dissolved and diluted with trichloromethane to make about 1 of norgestrel per 1 ml. Omg and ethinylestradiol 0.1 mg solution, as a control solution. According to the thin layer chromatography (General 0502) test, absorb 30 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with chloroform-methanol (9:1) as the developing solvent, it was developed, dried, sprayed with sulfuric acid-anhydrous ethanol (1:1), and heated at 105 ° C. To develop color. The position and color of the main spots of the two components shown in the test solution should be the same as the corresponding main spots of the control solution.
examination
should comply with the relevant provisions under the pill (General rule 0108).
Content determination
- Take 10 pills of this product, remove the coating, put it in a 20ml measuring flask, add about 12ml of ethanol, warm to dissolve Norgestrel and Ethinyl estradiol, and let it cool, dilute to the scale with ethanol, shake, filter, take the filtrate as the test solution; Take the other Norgestrel and Ethinyl estradiol reference substance, precision weigh, acetonitrile was added for dissolution and quantitative dilution to prepare a solution containing about 0.15mg of Norgestrel and 15ug of ethinyl estradiol per 1 ml as a control solution.
- the sample solution and the reference solution were respectively lml in precision volume, and were placed in a plug Erlenmeyer flask, respectively, and ethanol 3ml and basic trinitrophenol solution 4ml were accurately added, followed by tamponade, it was left to stand in the dark for 80 minutes, and the absorbance was measured at a wavelength of 490nm by ultraviolet-visible spectrophotometry (General rule 0401) and calculated.
- ethinylestradiol precision 2ml of the test solution and the reference solution were separately placed in a plug Erlenmeyer flask. After cooling in an ice bath for 30 seconds, sulfuric acid-ethanol (4l) was added to each precision solution. 8ml (the speed must be the same), with the addition and shaking, after adding continue to cool for 30 seconds, take out, at room temperature for 20 minutes, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 530nm and calculated.
category
birth control pills.
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:43:27
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Product Name: Norgestrel Visit Supplier Webpage Request for quotationCAS: 6533-00-2
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Multiple SpecificationsSpot supply
Product Name: Norgestrel Visit Supplier Webpage Request for quotationCAS: 6533-00-2
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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