17-ethynyl-18-methyl-19-nortestosteron
D(minus)-norgestrel
CAS: 797-63-7
Molecular Formula: C21H28O2
17-ethynyl-18-methyl-19-nortestosteron - Names and Identifiers
| Name | D(minus)-norgestrel |
| Synonyms | postinor norplant2 norplantii microluton Levonorgestrel Norgestrel (L-) D(minus)-norgestrel 17-ethynyl-18-methyl-19-nortestosteron 17-ethynyl-18-methyl-19-nortestosterone 18-methyl-17-alpha-ethynyl-19-nortestosterone 13-ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one 13-ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one 17-alpha-ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one 13-ethyl-17-hydroxy-19-dinor-17-alpha-pregn-4-en-20-yn-3-on(+)-1 17-beta-hydroxy-18-methyl-19-nor-17-alpha-pregn-4-en-20-yn-3-one (14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one (non-preferred name) |
| CAS | 797-63-7 |
| EINECS | 212-349-8 |
| InChI | InChI=1/C21H28O2/c1-3-20-11-9-17-16-8-6-15(22)13-14(16)5-7-18(17)19(20)10-12-21(20,23)4-2/h2,13,16-19,23H,3,5-12H2,1H3/t16?,17?,18?,19-,20?,21-/m0/s1 |
17-ethynyl-18-methyl-19-nortestosteron - Physico-chemical Properties
| Molecular Formula | C21H28O2 |
| Molar Mass | 312.45 |
| Density | 1.0697 (rough estimate) |
| Melting Point | 206°C |
| Boling Point | 392.36°C (rough estimate) |
| Specific Rotation(α) | D20 -32.4° (c = 0.496 in CHCl3) |
| Flash Point | 195.4°C |
| Water Solubility | 10mg/L(temperature not stated) |
| Solubility | It is dissolved in chloroform, slightly soluble in methanol, and insoluble in water. |
| Vapor Presure | 2.32E-10mmHg at 25°C |
| Appearance | White or white-like crystalline powder |
| Color | Crystals from MeOH/CHCl3 |
| Merck | 13,6736 |
| pKa | 13.09±0.40(Predicted) |
| Storage Condition | Sealed in dry,2-8°C |
| Refractive Index | 1.4900 (estimate) |
| MDL | MFCD00199013 |
| Use | Progesterone drugs, for irregular menstruation, uterine bleeding, endometrial shift, etc |
17-ethynyl-18-methyl-19-nortestosteron - Risk and Safety
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R40 - Limited evidence of a carcinogenic effect R60 - May impair fertility |
| Safety Description | S22 - Do not breathe dust. S36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | JF8225000 |
| HS Code | 2937230000 |
17-ethynyl-18-methyl-19-nortestosteron - Standard
Authoritative Data Verified Data
This product is (a)-13-ethyl -17-base -18,19-bis-desmethyl-17a-pregnan-4-en-20-alkyn-3-one. The content of C21H2802 should be 97.0% ~ 103.0%.
Last Update：2024-01-02 23:10:35
17-ethynyl-18-methyl-19-nortestosteron - 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 233~239°C, and the melting distance is within 5°C.
specific rotation
take this product, precision weighing, plus chloroform dissolved and quantitatively diluted to make a solution containing about 20mg per lml, according to the law (General 0621), the specific rotation is from one 30 ° to one 35 °.
Last Update：2022-01-01 11:35:39
17-ethynyl-18-methyl-19-nortestosteron - 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 726).
Last Update：2022-01-01 11:35:39
17-ethynyl-18-methyl-19-nortestosteron - Exam
Authoritative Data Verified Data
ethynyl
precision weighing this product about 0.lg, add tetrahydrofuran 40ml to dissolve, add 0701% silver nitrate solution, according to the potential titration method (general rule), with sodium hydroxide titration solution (O.lmol/L) titration. Each l of sodium hydroxide titration solution (0.1 mol/L) corresponds to 2.503mg of ethynyl. This product contains ethynyl group should be 7.81% ~ 8.18%.
Related substances
take this product, add the mobile phase to dissolve and make a solution containing about 75ug per lml as the 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 chromatographic 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 11:35:40
17-ethynyl-18-methyl-19-nortestosteron - 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 (70:30) was used as the mobile phase; The detection wavelength was 240nm. Levonorgestrel and megestrol acetate were dissolved and diluted with mobile phase to prepare solutions containing levonorgestrel 75ug and megestrol acetate 0.5mg in 1 mL respectively. 20ul was injected into human liquid chromatograph and the chromatogram was recorded. The theoretical plate number shall not be less than 2000 based on the peak of levonorgestrel, and the separation degree between the peak of levonorgestrel and the peak of megestrol acetate shall meet the requirements.
assay
take an appropriate amount of this product, accurately weigh it, add the mobile phase to dissolve and quantitatively dilute it to make a solution containing about 75ug per lml, shake it well, and use it as a test solution, 20M1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. Another reference substance of levonorgestrel 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 11:35:40
17-ethynyl-18-methyl-19-nortestosteron - Category
Authoritative Data Verified Data
progesterone drugs.
Last Update：2022-01-01 11:35:40
17-ethynyl-18-methyl-19-nortestosteron - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:35:41
17-ethynyl-18-methyl-19-nortestosteron - Levonorgestrel tablets
Authoritative Data Verified Data
This product contains levonorgestrel (C21H2802) should be 90.0% to 110% of the label.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (equivalent to 37.5mg of levonorgestrel), add about 200ml of chloroform in several portions, stir well, and use a G4 vertical melting funnel for Suction filtration under reduced pressure, the residue and filter were washed with chloroform, the filtrate was combined, evaporated to dryness on a water bath, allowed to cool, accurately added 5ml of chloroform, and measured according to law (General rule 0621). The optical rotation should be levorotatory, not less than 0.18°C.
- 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 and place it in a 10ml measuring flask (0.75mg specification) or 20ml measuring flask (1.5mg specification), according to the method under the content determination item, from the "addition of appropriate amount of mobile phase", the content shall be determined according to the law, and the content shall be calculated by the peak area according to the external standard method, and shall comply with the regulations (General rule 0941).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- determined by HPLC (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (70:30) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 2000 based on the peak of levonorgestrel.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 3.75mg equivalent to levonorgestrel), put it in a 50ml measuring flask, add an appropriate amount of mobile phase, ultrasonic dissolution of levonorgestrel, cool, dilute to the scale with mobile phase, shake, filter, take the continued filtrate as the test solution, take 20 u1 with precision, levonorgestrel content was determined by the method under the item.
category
Same as levonorgestrel.
specification
(1)0.75mg (2)1.5mg
storage
protected from light and sealed.
Last Update：2022-01-01 11:35:41
17-ethynyl-18-methyl-19-nortestosteron - Levonorgestrel and Ethinylestradiol Tablets（Triphasic）
Authoritative Data Verified Data
This product contains levonorgestrel (C21H2802) and ethinyl estradiol (C20H24O2) should be 90.0% to 115.0% of the label amount.
trait
This product is sugar-coated tablet or film-coated tablet (respectively yellow, white, brown three colors), white or white after removing the coating.
identification
In the chromatogram recorded under the content uniformity item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
examination
- Content uniformity was measured by high performance liquid chromatography (General 0512).
- chromatographic 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 resolution of the levonorgestrel peak from the ethinyl estradiol peak should be satisfactory.
- determination: Take 1 tablet of this product, put it in a 10ml measuring flask, add appropriate amount of mobile phase, sonicate for about 30 minutes to dissolve levonorgestrel and ethinyl estradiol, let it cool, dilute to scale with mobile phase, shake well, centrifuge, take the supernatant as the test solution, inject 50ul into the liquid chromatograph, record the chromatogram; Take appropriate amount of levonorgestrel and ethinylestradiol reference, precisely weigh, methanol was added respectively to dissolve and quantitatively dilute to prepare the reference solution (1) containing 5ug of levonorgestrel and 3UG of ethinyl estradiol per 1 ml (for yellow tablets); control Solution (2) containing 7.5ug of levonorgestrel and 4mg of ethinyl estradiol per 1 mL (for white tablets, use control solution (3) containing 12.5ug of levonorgestrel and 3UG of ethinyl estradiol per 1 ml) (For Brown tablets), the same method. The content of levonorgestrel and ethinyl estradiol in each tablet was calculated by peak area according to external standard method. The limit shall be ± 20% and shall be in accordance with the regulations (General rule 0941).
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), 0.0005% polysorbate 80 solution was used as the dissolution medium, and the rotation speed was 50 rpm, after 45 minutes, 30ml of the solution was taken, filtered, 20ml of the initial filtrate was discarded, and the continued filtrate was taken as the test solution. Determined by high performance liquid chromatography (General 0512). The mobile phase was Methanol-Water (70:30). The detection wavelength of levonorgestrel was 247mn. Ethinyl estradiol was measured with a fluorescence detector at an excitation wavelength of 285nm and an emission wavelength of 3lonm. The sample solution 100u1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. Another reference substance of levonorgestrel was accurately weighed, and the appropriate amount of ethanol was added, and quantitatively diluted into a solution containing 0.02mg per lml, as a reference stock solution (1 ) ; Take the reference substance of ethinyl estradiol, precision weighing, plus an appropriate amount of ethanol, ultrasonic to dissolve, cool, and quantitative dilution made per 1 ml containing O. A solution of oo8 mg as a control stock solution (2). Take 2ml of each of the above two kinds of reference stock Solutions respectively, put them in the same 200ml measuring flask, dilute to the scale with dissolution medium, shake well, and use them as reference solution for determination by the same method, the dissolution amount of each tablet was calculated by the peak area according to the external standard method. Limits for both levonorgestrel and ethinylestradiol are 60% of the nominal amount and should be met.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
The average content is calculated by taking the results measured under the content uniformity.
category
birth control pills.
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:35:43
17-ethynyl-18-methyl-19-nortestosteron - Levonorgestrel and norestrol tablets
Authoritative Data Verified Data
This product contains levonorgestrel (C21H28O2) should be 90.0% ~ 115.0% of the label amount, containing ethinyl ether (C25H3202) should be 95.0% ~ 115.0% of the label amount.
trait
This product is a film-coated tablet, white or off-white after removal of the coating.
identification
- take an appropriate amount of fine powder of this product (equivalent to 0.15g of levonorgestrel), add about 200ml of chloroform in several portions, stir thoroughly, use a G4 vertical melting funnel to suction filter under reduced pressure, and wash the filter residue and filter with chloroform, the filtrates are combined, evaporated to dryness on a water bath, cooled, and then 20ml of chloroform is added precisely as a test solution. The optical rotation shall be levorotatory and not less than 0621 when measured according to law (General rule 0.18).
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take 2ml of the test solution under identification (1) as the test solution, and take 2ml of each of the reference solution and the reference solution of levonorgestrel under the content determination item, it was dried by evaporation on a water bath, allowed to cool, dissolved with 1 ml of chloroform, and used as a reference solution, and measured according to the method under the item of related substances. The position and color of the main spots of the two components displayed by the test solution should be the same as those displayed by the control solution.
examination
- for related substances, 2ml of the test solution under identification (1) is taken as the test solution; 2ml of the reference solution for the determination of the content is taken, it was dried on a water bath and allowed to cool. 2.5 of trichloromethane was added as a reference solution. According to the thin layer chromatography (General 0502) test, draw the reference solution 15m1 and the test solution 12.5ul, respectively, on the same silica gel G thin layer plate, with three gas methane methanol (96:4) for Development, spread out, dry, spray with freshly prepared 10% phosphomolybdic acid ethanol solution, dry at 105°C for 10 minutes, let cool, and inspect immediately. Test solution such as impurity spots, compared with the control solution showed the main spot, not deeper.
- Content uniformity 1 tablet of this product was taken and determined according to the method under the content determination item, starting from "placing in a 100ml measuring flask. According to the external standard method to calculate the content of Peak area, should comply with the provisions (General 0941).
- dissolution: according to the method for determination of dissolution and release (General rule 0931, second method), 0.8% sodium dodecyl sulfate solution was used as dissolution medium at 100 rpm, and operated according to law, after 60 minutes, take the appropriate amount of the solution, filter it, and take the filtrate as the test solution. Weigh the levonorgestrel reference substance about 30mg and the quinestrol reference substance about 15mg in the same 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, take 1 ml accurately, put it in a 100ml measuring flask, dilute it to the scale with dissolution medium, shake well, and use it as a reference solution. The dissolution amount of levonorgestrel and norestrol in each tablet was calculated by peak area according to the external standard method as determined by the method under the content determination item. The limits are 60% and 80% of the labeled amount respectively and shall be in accordance with the regulations.
- 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 220nm. The theoretical plate number shall be no less than 3000 as per levonorgestrel peak, and the separation degree of levonorgestrel peak and ethinyl estradiol peak shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 6mg equivalent to levonorgestrel), put in a 100ml measuring flask, add an appropriate amount of mobile phase, dissolve levonorgestrel and quinestrol by ultrasound, let them cool, dilute to scale with mobile phase, shake well, filter, take the continued filtrate as the test solution, take the continued filtrate 20 u1 accurately, injection into the liquid chromatograph, record the chromatogram; Take the reference substance of levonorgestrel and Ethinyl ether, precision weighing, adding mobile phase, dissolving and quantitatively diluting respectively to prepare a solution containing about 60ug of levonorgestrel and 30ug of ethinyl ether per lml, and determine with the same method, according to the external standard method to calculate the peak area, that is.
category
progesterone drugs.
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:35:44
17-ethynyl-18-methyl-19-nortestosteron - Compound levonorgestrel tablets
Authoritative Data Verified Data
This product contains levonorgestrel (C21H2802) and ethinyl estradiol (C20H2402) should be 90.0% to 115.0% of the label amount.
prescription
levonorgestrel 150mg
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 5 tablets of this product, ground fine, add chloroform 10ml fully stirred, filtered, take the filtrate 2ml plus basic trinitrophenol solution (take 0.6% trinitrophenol ethanol solution, 7% sodium hydroxide solution and dilute ethanol, immediately before using the same amount of mixed) 2ml, placed after 30 minutes, the solution is Brown yellow.
- Take appropriate amount of fine powder of this product (about 15mg equivalent to levonorgestrel), add about 200ml of chloroform in several portions, stir thoroughly, use G4 vertical funnel to suction filter under reduced pressure, and wash the filter residue and filter with chloroform, the filtrate was combined, evaporated to dryness on a water bath, allowed to cool, added 2ml of trichloromethane precisely, and measured by law with a 1dm microtube (General rule 0621). It should be left-handed and not less than 0.18 °.
- take 5 tablets of this product, grind, add chloroform 10ml, fully stirred, filtered, filtrate evaporated to dryness, Precision Add chloroform 1 ml to dissolve levonorgestrel and ethinylestradiol, as a test solution; another levonorgestrel and ethinyl estradiol control sample was dissolved and diluted with chloroform to prepare a solution containing levonorgestrel 0.75mg and ethinyl estradiol 0.15mg per 1 ml as a reference 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 a sulfuric acid-anhydrous ethanol (1:1) mixture, 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.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- two items (3) and (4) above can be selected as one item.
examination
-
The content uniformity of
- shall be calculated from the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), 0.0005% polysorbate 80 solution was used as the dissolution medium, and the rotation speed was 75 rpm, according to the law, 30ml of the solution was taken after 60 minutes, filtered, 20ml of the initial filtrate was discarded, and the continued filtrate was taken as the test solution. Determined by high performance liquid chromatography (General 0512). The mobile phase consisted of acetonitrile-water (60:40). The detection wavelength of levonorgestrel was 247mn. Ethinyl estradiol was measured with a fluorescence detector at an excitation wavelength of 285nm and an emission wavelength of 3 l0nm. The number of theoretical plates shall not be less than 5000 based on the peak of levonorgestrel. 100ul of sample solution was accurately measured and human liquid chromatograph was injected, and the chromatogram was recorded. Another reference substance of levonorgestrel was accurately weighed, and appropriate amount of ethanol was added, and the quantitative dilution is made into a solution containing about 0.75mg per 1 ml, which is used as the reference stock solution (1); Take the reference substance of ethinyl estradiol, An appropriate amount of ethanol was added, dissolved by sonication, allowed to cool, and quantitatively diluted to prepare a solution containing about 0.15mg per 1 ml as a reference stock solution (2). 2ml of each of the stock Solutions (1) and (2) of the reference substance were accurately weighed, placed in a 100ml measuring flask, diluted to the scale with acetonitrile-dissolution medium (1:1), and shaken uniformly. Take 2ml of precision, 100ml flask, diluted with dissolution medium to scale, shake, as a reference solution, the same method. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. Limits for both levonorgestrel and ethinylestradiol are 60% of the nominal amount and should be met.
- 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 applicability test with eighteen alkyl silane bonded silica as filler; Acetonitrile-water (60:40) as mobile phase; the detection wavelength is 220nmD. The number of theoretical plates shall not be less than 5000 according to the calculation of levonorgestrel peak, and the separation degree of levonorgestrel peak and ethinyl estradiol peak shall be greater than 2.5.
- 10 tablets of levonorgestrel and ethinyl estradiol were placed in 10ml measuring flasks respectively, appropriate amount of mobile phase was added, and the mixture was ultrasonicated for 40 minutes and shaken from time to time to dissolve levonorgestrel and ethinyl estradiol, and allowed to cool, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution, and inject 50ul into the liquid chromatograph with precision, record the chromatogram; Take the reference substance of levonorgestrel and ethinylestradiol, precision weighing, adding acetonitrile, ultrasonic dissolution, cold, and quantitative dilution of levonorgestrel 0.75mg and ethinylestradiol 0.15mg per 1 mL solution, precision volume to take 2ml, in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, and measure with the same method. According to the external standard method, the content of each tablet is calculated by the peak area, and the average content is obtained.
category
birth control pills.
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:43:14
17-ethynyl-18-methyl-19-nortestosteron - Compound Levonorgestrel Plls
Authoritative Data Verified Data
This product contains levonorgestrel (C21H2802) and ethinyl estradiol (C20H2402) should be 90.0% to 115.0% of the label amount.
prescription
levonorgestrel 150mg
Ethinylestradiol 30Mg
Made of 1000 pills
trait
This product is sugar-coated pills.
identification
- take 1 pill of this product, remove the sugar coating, add about 2ml of ethanol, place it in a water bath and heat it to dissolve levonorgestrel and ethinyl estradiol, and let it cool, add 2ml of basic trinitrophenol solution (ethanol solution of 0.6% trinitrophenol, 7% sodium hydroxide solution and dilute ethanol, mix the same amount immediately before use), place for 30 minutes, and the solution is brown-yellow.
- take 100 pills of this product, remove the coating, put it in a small Erlenmeyer flask, add water 20ml, warm it slightly to dissolve levonorgestrel and ethinyl estradiol, let it cool, and transfer it to a separatory funnel, the conical flask was washed twice with water, 5 times each time, 1, the combined washing solution was placed in the separating funnel, and the mixture was shaken with ether for 3 times, 40ml each time. The water layer was discarded, and the ether layer extract was combined, wash twice with water, 25ml each time, and filter the ether layer through a filter covered with absorbent cotton and anhydrous sodium sulfate, swing the ether, add chloroform to dissolve the residue, and transfer to a 2ml measuring flask, dilute with chloroform to the scale, shake (filter if necessary), with 1dm microtube determination according to law (General 0621), should be left-handed, not less than 0.18 °.
- Take 10 pills of this product, remove the coating, put it in a small beaker, add about 4ml of water, warm it slightly to dissolve levonorgestrel and ethinylestradiol, let it cool, move it into a separatory funnel, add 20ml of diethyl ether, after washing with shaking water, the ether layer was filtered through a filter with cotton wool and anhydrous sodium sulfate, placed in an evaporation dish, and washed with ether. The residue was dissolved by adding 0.3ml of chloroform, as a test solution; Another control of levonorgestrel and ethinyl estradiol was taken, dissolved and diluted with chloroform to make about 1 ml of levonorgestrel 5.Omg with ethinylestradiol l. 0 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 a sulfuric acid-anhydrous ethanol (1:1) mixture, 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
- 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 (60:40) as mobile phase; The detection wavelength was 220nm. The number of theoretical plates shall not be less than 5000 based on the peak of levonorgestrel, and the separation degree between the peak of levonorgestrel 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 pills of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 0.75mg equivalent to levonorgestrel), put it in a 10ml measuring flask, precision adding 1ml of internal standard solution, add appropriate amount of mobile phase, ultrasonic dissolution, cool, dilute to scale with mobile phase, shake, filter, take filtrate as test solution, take 20u1 injection liquid chromatograph, record chromatogram; another reference substance of levonorgestrel and ethinylestradiol was carefully weighed, dissolved and quantitatively diluted with acetonitrile to make a solution containing levonorgestrel 0.75mg and ethinylestradiol 0.15mg per 1ml, take 1ml of the solution and 1ml of the internal standard solution, put it in a 10ml measuring flask, dilute it to the scale with the mobile phase, shake it well, and measure it with 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 13:43:15
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