21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Names and Identifiers
Name | halcinonide
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Synonyms | halcimat Halcimat halciderm halcinonide Halcinonide (200 mg) 20-dione,21-chloro-9-fluoro-11-beta,16-alpha,17-trihydroxy-pregn-4-ene-cyc 21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione (11β,16α)-21-Chloro-9-fluoro-11-hydroxy-16,17-[(1-Methylethylidene)bis(oxy)]pregn-4-ene-3,20-dione 21-chloro-9-alpha-fluoro-11-beta-hydroxy-16-alpha,17-alpha-isopropylidenedioxypregn-4-ene-3,20-dione Pregn-4-ene-3,20-dione, 21-chloro-9-fluoro-11-beta,16-alpha,17-trihydroxy, cyclic-16,17-acetal with acetone Pregn-4-ene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11beta,16alpha)-
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CAS | 3093-35-4 699012-35-6
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EINECS | 221-439-6 |
InChI | InChI=1/C24H32ClFO5/c1-20(2)30-19-10-16-15-6-5-13-9-14(27)7-8-21(13,3)23(15,26)17(28)11-22(16,4)24(19,31-20)18(29)12-25/h9,15-17,19,28H,5-8,10-12H2,1-4H3/t15?,16?,17?,19-,21?,22?,23?,24-/m1/s1 |
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Physico-chemical Properties
Molecular Formula | C24H32ClFO5
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Molar Mass | 454.96 |
Density | 1.1567 (estimate) |
Melting Point | 264-265° (dec) |
Boling Point | 564.3±50.0 °C(Predicted) |
Specific Rotation(α) | D25 +155° (CHCl3) |
Flash Point | 295.1°C |
Solubility | Chloroform (Slightly), Ethyl Acetate (Slightly) |
Vapor Presure | 4.38E-15mmHg at 25°C |
Appearance | Solid |
Color | White to Off-White |
pKa | 13.19±0.70(Predicted) |
Storage Condition | -20°C Freezer |
Refractive Index | 1.566 |
Use | For corticosteroids, for the treatment of psoriasis and eczema dermatitis and other diseases |
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Risk and Safety
Hazard Symbols | Xn - Harmful

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Risk Codes | 63 - Possible risk of harm to the unborn child
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Safety Description | 36 - Wear suitable protective clothing.
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WGK Germany | 3 |
RTECS | TU5010200 |
HS Code | 2937220000 |
Toxicity | LD50 i.p. in mice: 150 mg/kg (Millonig, Yiakas) |
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Standard
Authoritative Data Verified Data
This product is 16a,17-[(l-methylethylidene) BIS (OXY)]-11 tooth hydroxy-21-chloro-9-fluoro pregnan-4-ene-3, 20-dione. The content of C24H32CIFO5 shall be 97.0% to 102.0% calculated as dry product.
Last Update:2024-01-02 23:10:35
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Odorless.
- This product is dissolved in chloroform, slightly soluble in methanol or ethanol, insoluble in water.
specific rotation
take this product, precision weighing, plus three gas methane dissolution and quantitative dilution of each lml containing about 10 mg of the solution, according to the law (General 0621), the specific rotation was 150 ° to 159 °.
Last Update:2022-01-01 13:40:10
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Preparation solution concentration reference
| 1mg | 5mg | 10mg |
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1 mM | 2.198 ml | 10.99 ml | 21.98 ml |
5 mM | 0.44 ml | 2.198 ml | 4.396 ml |
10 mM | 0.22 ml | 1.099 ml | 2.198 ml |
5 mM | 0.044 ml | 0.22 ml | 0.44 ml |
Last Update:2024-01-02 23:10:35
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, the retention time of the standard peak of the test solution should be consistent with the retention time of the main peak of the control solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 498).
- This product shows the identification reaction of organic fluoride (General rule 0301).
- take about 15mg of this product, according to the oxygen flask combustion method (General rule 0703) for organic destruction, with water 20ml as the absorption liquid, once the combustion is complete, the solution shows chloride identification (1) response (General rule 0301).
Last Update:2022-01-01 13:40:11
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Exam
Authoritative Data Verified Data
fluorine
take this product, according to the fluorine inspection method (General 0805) determination, fluorine content should be 3.4% ~ 4.4%.
Related substances
take about 25mg of this product, put it in a 50ml measuring flask, add 38ml of methanol, ultrasonic to dissolve, dilute it with water to the scale, shake well, and use it as a test solution, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. According to the chromatographic conditions under the content determination item, take 10 u1 of the test solution and the control solution, respectively inject the human liquid chromatograph, record the chromatogram to 2.5 times 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 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.05 times smaller than the main peak area of the control solution were ignored.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update:2022-01-01 13:40:11
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - 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 a filler; Methanol-water (70:30) was used as a mobile phase; And the detection wavelength was 240mn. Take halcinonide, dissolve and dilute with methanol to make a solution containing about 1 mg per 1 ml, take 25ml, Add 10ml of 1 mol/L sodium hydroxide solution, shake, heat and reflux for 1 hour, and let it cool, adjust pH value to Neutral with 1 mol/L hydrochloric acid solution, transfer to 50ml measuring flask, dilute to scale with methanol, shake well, take 5ml, put into 25ml measuring flask, dilute to scale with mobile phase, shake well, take lOul to inject human liquid chromatograph, adjust the flow rate so that the retention time of the peak of the halcinonide is about 12 minutes; The peak of the halcinonide and the peak of the degradation product (relative retention time is about 1.1) the degree of separation should be greater than 1.7.
assay
take about 25mg of this product, accurately weigh, put it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take 5ml accurately, put it in a 50ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, take 10 u1 with precision, inject human liquid chromatograph, record chromatogram; Take another halcinonide reference substance, and determine with the same method. According to the external standard method to calculate the peak area, that is.
Last Update:2022-01-01 13:40:12
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Category
Authoritative Data Verified Data
adrenocortical hormone drugs.
Last Update:2022-01-01 13:40:12
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Storage
Authoritative Data Verified Data
Last Update:2022-01-01 13:40:13
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Halcinonide Ointment
Authoritative Data Verified Data
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 90.0% ~ 110.0%.
trait
This product is milky white soft.
identification
- take an appropriate amount of this product (about 2mg equivalent to halcinolone acetonide), place it in a separatory funnel, add 50ml of cyclohexane and 25ml of methanol, and shake to dissolve it all, the lower layer was placed in another separatory funnel containing 50ml of 5% aluminum potassium sulfate solution, and the upper layer was extracted twice (15ml,10ml) with methanol-10% sodium chloride solution (5:1), the lower layer was mixed in the above separatory funnel, extracted 4 times with chloroform (50ml,25ml,5ml,5ml), and the chloroform solution was combined, A beaker was filtered through a funnel with about 10g of anhydrous sodium sulfate, dried by evaporation on a water bath, and the residue was dissolved with 1 ml of three gas methane-methanol (9:1) as a test solution; another halcinolone acetonide control was dissolved in chloroform-methanol (9:1) and diluted to prepare a solution containing about 2mg of halcinolone acetonide per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with chloroform-ethyl acetate (3:1) as the developing solvent, expand, dry, dry at 105°C for 1 min, spray with basic tetrazolium blue test solution, and immediately check that the position and color of the main spot of the test solution should be the same as the main spot of the reference solution.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
should comply with the relevant provisions under ointment (General rule 0109).
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; Methanol-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 calculation of halcinonide peak, and the separation degree between halcinonide peak and internal standard substance peak shall meet the requirements.
- preparation of internal standard solution progesterone was taken, dissolved with mobile phase and diluted to give a solution containing about 0.15mg per 1 ml.
- determination method: take an appropriate amount of this product (about 1.25mg equivalent to halcinolone acetonide), weigh it accurately, put it in a 50ml measuring flask, add about 30ml of methanol, and heat it in a 80°C water bath for 2 minutes, shake to dissolve halcinonide, cool, Precision Add internal standard solution 5ml, dilute to the scale with methanol, shake, ice bath for more than 2 hours, take it out and quickly filter, the filtrate was taken as the test solution at room temperature, and 20u1 was injected into the human liquid chromatograph to record the chromatogram. Another sample of 12.5mg was accurately weighed and placed in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take 10ml of the solution and 5ml of the internal standard solution accurately, put it in a 50ml measuring flask, dilute to the scale with methanol, shake well, and measure with the same method. According to the internal standard method to calculate the peak area, that is.
category
Same as halcinolone acetonide.
specification
10g:1Omg
storage
sealed and stored in a cool place.
Last Update:2022-01-01 13:40:13
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Haleinonide Cream
Authoritative Data Verified Data
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 85.0% ~ 115.0%.
trait
This product is white cream.
identification
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 control solution.
examination
should comply with the relevant provisions under Cream (General rule 0109).
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; Methanol-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 calculation of halcinonide peak, and the separation degree between halcinonide peak and internal standard substance peak shall meet the requirements.
- preparation of internal standard solution progesterone was taken, dissolved with mobile phase and diluted to give a solution containing about 0.15mg per 1 ml.
- determination method: take an appropriate amount of this product (about 1.25mg equivalent to halcinolone acetonide), weigh it accurately, put it in a 50ml measuring flask, add about 30ml of methanol, and heat it in a 80°C water bath for 2 minutes, shake to dissolve halcinonide, cool, Precision Add internal standard solution 5ml, dilute to the scale with methanol, shake, ice bath for more than 2 hours, take it out and quickly filter, the filtrate was taken as the test solution at room temperature, and 20u1 was injected into the human liquid chromatograph to record the chromatogram. Another sample of 12.5mg was accurately weighed and placed in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take 10ml solution and 5ml internal standard solution accurately, put it in 50ml measuring flask, dilute to the scale with methanol, shake well, and measure with the same method. According to the internal standard method to calculate the peak area, that is.
category
Same as halcinolone acetonide.
specification
10g:lOmg
storage
sealed and stored in a cool place.
Last Update:2022-01-01 13:40:14
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Halcinolone acetonide film
Authoritative Data Verified Data
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 90.0% ~ 110.0%.
trait
This product is a colorless, slightly viscous, clear liquid.
identification
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 control solution.
examination
shall comply with the relevant provisions under the item of coating agent (General Principle 0119).
Content determination
take an appropriate amount of this product (about 2.5mg equivalent to halcinolone acetonide), weigh it accurately, put it in a 100ml measuring flask, shake with mobile phase to dissolve halcinolone acetonide and dilute it to the scale, shake it well, as a test solution. According to the chromatographic conditions under the content determination item of halcinolone acetonide, inject 20u1 into the liquid chromatograph with precise measurement, record the chromatogram; Take another 25mg of the halcinolone acetonide reference, weigh it accurately, put it into a 100ml measuring flask, add 74ml of methanol to shake to dissolve, dilute to scale with water, shake well, take 5ml with precision, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, and measure with the same method. According to the external standard method to calculate the peak area, that is.
category
Same as halcinolone acetonide.
specification
10g:lOmg
storage
sealed and stored in a cool place.
Last Update:2022-01-01 13:40:15
21-Chloro-9α-fluoro-11β-hydroxy-16α,17α-(isopropylidenebisoxy)pregn-4-ene-3,20-dione - Halcinonide Solution
Authoritative Data Verified Data
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 90.0% ~ 110.0%.
trait
This product is a colorless clear liquid, can be slightly viscous.
identification
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 control solution.
examination
- loading test according to the minimum loading test method (General 0942), should be in accordance with the provisions of the table below.
- others shall be in accordance with the relevant provisions under the item of paint (General rule 0118).
Content determination
take an appropriate amount of this product (about 25mg equivalent to halcinolone acetonide), put it in a 100ml measuring flask, dilute it to the scale with methanol, shake it, take 5ml for precision measurement, put it in a 50ml measuring flask, dilute to the scale with the mobile phase, shake, as a test solution. According to the determination of the content of the method under the item of the determination of the content of.
category
Same as halcinolone acetonide.
specification
(1)0.1 % (2)0.025%
storage
light shielding, closed storage.
Last Update:2022-01-01 13:40:16