Name | halcinonide |
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)- |
CAS | 3093-35-4 699012-35-6 |
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 |
Molecular Formula | C24H32ClFO5 |
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 |
Hazard Symbols | Xn - Harmful![]() |
Risk Codes | 63 - Possible risk of harm to the unborn child |
Safety Description | 36 - Wear suitable protective clothing. |
WGK Germany | 3 |
RTECS | TU5010200 |
HS Code | 2937220000 |
Toxicity | LD50 i.p. in mice: 150 mg/kg (Millonig, Yiakas) |
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.
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 °.
1mg | 5mg | 10mg | |
---|---|---|---|
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 |
take this product, according to the fluorine inspection method (General 0805) determination, fluorine content should be 3.4% ~ 4.4%.
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.
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
not more than 0.1% (General rule 0841).
measured by high performance liquid chromatography (General 0512).
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.
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.
adrenocortical hormone drugs.
sealed storage.
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 90.0% ~ 110.0%.
This product is milky white soft.
should comply with the relevant provisions under ointment (General rule 0109).
Same as halcinolone acetonide.
10g:1Omg
sealed and stored in a cool place.
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 85.0% ~ 115.0%.
This product is white cream.
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.
should comply with the relevant provisions under Cream (General rule 0109).
Same as halcinolone acetonide.
10g:lOmg
sealed and stored in a cool place.
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 90.0% ~ 110.0%.
This product is a colorless, slightly viscous, clear liquid.
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.
shall comply with the relevant provisions under the item of coating agent (General Principle 0119).
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.
Same as halcinolone acetonide.
10g:lOmg
sealed and stored in a cool place.
This product contains halcinolone acetonide (C24H32C1F05) should be the label amount of 90.0% ~ 110.0%.
This product is a colorless clear liquid, can be slightly viscous.
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.
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.
Same as halcinolone acetonide.
(1)0.1 % (2)0.025%
light shielding, closed storage.