Beclomethasone dipropionate
Beclometasone Dipropionate
CAS: 5534-09-8
Molecular Formula: C28H37ClO7
Beclomethasone dipropionate - Names and Identifiers
| Name | Beclometasone Dipropionate |
| Synonyms | beclacin becotide becloval beclovent benconase becloforte Beclometasone Dipropionate Beclomethasone dipropionate beclometasone17,21-dipropionate (9Z,11E,13Z)-octadeca-9,11,13-trienoic acid 9-chloro-16-beta-methyl-11-beta,17,21-trihydroxy-pregna-1-4-diene-20-dione (11beta,16beta)-9-chloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate |
| CAS | 5534-09-8 |
| EINECS | 226-886-0 |
| InChI | InChI=1/C28H37ClO7/c1-6-23(33)35-15-22(32)28(36-24(34)7-2)16(3)12-20-19-9-8-17-13-18(30)10-11-25(17,4)27(19,29)21(31)14-26(20,28)5/h10-11,13,16,19-21,31H,6-9,12,14-15H2,1-5H3/t16-,19-,20?,21-,25-,26-,27?,28-/m0/s1 |
Beclomethasone dipropionate - Physico-chemical Properties
| Molecular Formula | C28H37ClO7 |
| Molar Mass | 521.04 |
| Density | 1.0766 (rough estimate) |
| Melting Point | 117-120 C |
| Boling Point | 613.3°C (rough estimate) |
| Specific Rotation(α) | D +98.0° (c = 1.0 in dioxane) |
| Solubility | Soluble in Dichloromethane, Ethyl Acetate and Methanol |
| Appearance | White crystalline powder |
| Color | White |
| Maximum wavelength(λmax) | ['238nm(EtOH)(lit.)'] |
| Merck | 14,1019 |
| pKa | 13.02±0.70(Predicted) |
| Storage Condition | Sealed in dry,2-8°C |
| Refractive Index | 1.4429 (estimate) |
| MDL | MFCD00135613 |
| Use | Adrenocortical hormone drugs can be used to treat various inflammatory skin diseases. |
Beclomethasone dipropionate - Risk and Safety
| Risk Codes | R60 - May impair fertility R61 - May cause harm to the unborn child R36/37/38 - Irritating to eyes, respiratory system and skin. R20/21/22 - Harmful by inhalation, in contact with skin and 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.) S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| WGK Germany | 3 |
| RTECS | TU3805000 |
| HS Code | 29372100 |
| Toxicity | LD50 oral in rat: > 3750mg/kg |
Beclomethasone dipropionate - Standard
Authoritative Data Verified Data
This product is 16B-methyl-11B,17a,21-trihydroxy-9a-chlorogestatin-l, 4-dien-3, 20-diketo-17, 21-dipropionate. The content of C28H37C107 shall be between 97.0% and 103.0% based on the dry product.
Last Update：2024-01-02 23:10:35
Beclomethasone dipropionate - Trait
Authoritative Data Verified Data
- This product is white or off-white powder; Odorless.
- This product is soluble in acetone or chloroform, soluble in methanol, slightly soluble in ethanol, almost insoluble in water.
specific rotation
take this product, precision weighing, plus dioxane dissolution and quantitative dilution of each lml solution containing about 10 mg, according to the law (General 0621), the specific rotation was 88 ° to 94 °.
Last Update：2022-01-01 11:35:19
Beclomethasone dipropionate - 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.
- take this product, precision weighing, plus ethanol dissolution and quantitative dilution to make a solution containing about 20ug per lml, according to UV-visible spectrophotometry (General 0401) determination, there is a maximum absorption at the wavelength of 239nm, and the absorbance is 0.57 to 0.60; The absorbance ratio at the wavelength of 239nm to 263nm should be 2.25 to 2.45.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 71).
Last Update：2022-01-01 11:35:20
Beclomethasone dipropionate - Exam
Authoritative Data Verified Data
Related substances
take this product, add chloroform-methanol (9:1) dissolved and diluted to make a solution containing about 3mg per 1 ml, as a test solution; Take lml, in a 50ml measuring flask, dilute to the scale with chloroform-methanol (9:1) and shake to a control solution. According to the thin layer chromatography (General 0502) test, Draw 5 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with dichloroethane-methanol-water (95:5:0.2) as the developing solvent, expand, dry, dry at 105°C for 10 minutes, let cool, spray with basic tetrazolium blue test solution, and immediately check. Test solution such as impurity spots, not more than 2, its color and the control solution of the main spot comparison, not deeper.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 11:35:21
Beclomethasone dipropionate - 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; Methanol-water (74:26) was used as the mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 2500 calculated by beclomethasone dipropionate peak, and the degree of separation between beclomethasone dipropionate peak and internal standard substance peak shall be greater than 4.0. Preparation of internal standard solution methyltestosterone was taken, dissolved and diluted with mobile phase to prepare a solution containing about 0.12mg of each solution.
assay
take about 12.5mg of this product, accurately weigh it, put it in a 100ml measuring flask, add 74ml of methanol to dissolve it, dilute it with water to the scale, and shake it well; take 10ml of the solution and 5ml of the internal standard solution, put it in a 50ml measuring flask, dilute it to the scale with the mobile phase, shake it, and inject 20u1 into the liquid chromatograph, the chromatogram was recorded; Another reference substance of beclomethasone dipropionate was determined by the same method. According to the internal standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:35:22
Beclomethasone dipropionate - Category
Authoritative Data Verified Data
adrenocortical hormone drugs.
Last Update：2022-01-01 11:35:22
Beclomethasone dipropionate - Storage
Authoritative Data Verified Data
sealed, protected from light.
Last Update：2022-01-01 11:35:22
Beclomethasone dipropionate - Beclomethasone dipropionate Inhalation Aerosol
Authoritative Data Verified Data
This product is beclomethasone dipropionate solution type or suspension type quantitative Inhalation Aerosol. This product contains beclomethasone dipropionate (C28H37C107) should be 85.0% to 120.0% of the label.
trait
The liquid medicine of this product in the pressure-resistant container should be white suspension; High pressure valve, the liquid is sprayed out as mist particles.
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 reference solution.
- take 1 bottle of this product, drill a small hole in the aluminum cover, insert the injection needle with a dry rubber tube (do not contact with the liquid surface), one end of the rubber tube into the water, after vaporizing and volatilizing the propellant, the aluminum cap was removed, and the remaining propellant in the bottle was removed on the water bath. Cyclohexane (3ml) was added to wash the contents, and the mixture was left to stand and filtered. Wash for 3 times, filter with the same filter paper, remove cyclohexane with hot air from the residue in the bottle and on the filter paper, add 50ml of anhydrous ethanol to dissolve, filter, take a proper amount of continued filtrate (about 1 mg equivalent to beclomethasone dipropionate), dilute to 50ml with absolute ethanol, and measure by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 239nm.
examination
- fine particle dose inhalation preparation fine particle aerodynamic property measurement method (General rule 0951 method 1) was performed by placing 30ml of ethanol receiving liquid in the lower conical flask and 7ml of ethanol receiving liquid in the upper conical flask. Take this product, fully shake, spray 5 times, pressure spray 20 Times (pay attention to each jet interval of 5 seconds and slowly shake), clean the specified parts with appropriate amount of ethanol, combine the wash solution with the receiver solution in the lower conical flask (H), place it in a 50ul measuring flask, dilute it to the scale with ethanol, fully shake it, filter it, and take an appropriate amount of the continued filtrate with precision, quantitatively dilute with ethanol to make a solution containing about 10ug per lml, and according to the chromatographic conditions under the content determination item, take 50-injection liquid chromatograph for precise measurement; Take the reference substance of beclomethasone dipropionate for precise weighing, ethanol was added to dissolve and quantitatively diluted to prepare a solution containing 10ug per 1 ml, which was determined by the same method. According to the external standard method, the amount of fine particles shall not be less than 20% of the labeled amount of aerosol containing beclomethasone dipropionate 50 ~ 100ug per aerosol, and the amount of aerosol containing beclomethasone dipropionate 100ug or more per aerosol, the amount of fine particle drug should be in accordance with the regulations.
- leakage rate: Take 12 bottles of test article, remove the outer package, clean the surface with ethanol, place them at room temperature vertically (upright) for 24 hours, and weigh them accurately (W1) then place it at room temperature for 72 hours (accurate to 30 minutes), then weigh the valve precisely (W2), place it at 2-8°C for cooling, and then quickly drill a small hole on the valve, place at room temperature, separate the bottle from the valve after complete vaporization of the propellant, wash it with ethanol, dry it at room temperature, and weigh it accurately (W3) respectively, the annual leakage rate per bottle was calculated according to the following equation. The average annual leakage rate should be less than 3.5%, and not more than 1 bottle 5%.
- In addition to the uniformity of the delivered dose and the amount per spray, the relevant provisions under aerosol should be met (General rule 0113).
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 (74:26) as mobile phase; Detection wavelength of 240mn. The number of theoretical plates is not less than 2500 calculated from the peak of beclomethasone dipropionate.
- the method of measuring the content of this product, using anhydrous ethanol as absorbent, and illuminating aerosol (General rule 0113), quantitative dilution with absolute ethanol was made to contain 0.lmg solution, as a test solution, take 20u1 injection liquid chromatograph for precise measurement, record color chart; Take beclomethasone dipropionate reference substance, precision weighing, absolute ethanol was added to dissolve and quantitatively diluted to make each 1 ml containing 0.lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as beclomethasone dipropionate.
specification
- 200g/vial, containing beclomethasone dipropionate 50ug/vial.
- 200 ml per vial, containing beclomethasone dipropionate 80ug per vial.
- 200 ml per vial, containing 100ug beclomethasone dipropionate per vial.
- 200g/vial, containing beclomethasone dipropionate 200ug/vial.
- 200g/vial, containing beclomethasone dipropionate 250ug/vial.
- each bottle contains 80 μl of beclomethasone dipropionate 250ug.
storage
sealed and kept in a cool dark place.
Last Update：2022-01-01 11:35:23
Beclomethasone dipropionate - Beclomethasone dipropionate powder for inhalation
Authoritative Data Verified Data
This product is a powder aerosol for inhalation made of micronized beclomethasone dipropionate (0.5 ~ lOum) and suitable auxiliary materials into capsules, which is used in a special device. The content of beclomethasone dipropionate (C28H37C107) shall be between 90.0% and 115.0% of the label amount.
trait
This product is a hard capsule for human use, containing white powder.
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 reference solution.
- The filtrate under the content uniformity was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of Nm.
examination
- Content uniformity take 1 capsule of this product, pour the content into a 10ml measuring flask, wash the inner wall of the capsule with anhydrous ethanol, incorporate the lotion into the measuring flask, dilute to the scale with anhydrous ethanol, shake well, filter with filter membrane (0.45um), take the filtrate, according to UV-visible spectrophotometry (General rule 0401), measure absorbance at the wavelength of 238nm, precision weighing, plus anhydrous ethanol dissolved and quantitatively diluted into each lml containing about 10ug of the solution, the same method for the determination of absorbance, calculate the content. Except for the limit of ± 20%, the provisions (General 0941) shall be met.
- fine particle dosage: Take 10 granules of this product for determination by measuring the aerodynamic characteristics of fine particles in human inhalation preparation (General rule 0951 first method), add internal standard solution (take appropriate amount of testosterone propionate, dissolve it with methanol and dilute it to make a solution containing about 40ug per 1 ml, shake well) 5ml and methanol 25ml in the second-order distribution bottle H, as receiving fluid. Clean the specified parts, combine the washing solution with the receiver liquid in the second-stage distribution bottle H, place it in a 50ml measuring flask, dilute it to the scale with methanol, shake well, and adjust the chromatographic conditions under the content determination item, 20u1 was injected into human liquid chromatograph, and the chromatogram was recorded. Another reference substance of beclomethasone dipropionate, precision weighing, dissolving with methanol and quantitatively diluting to make a solution containing about 40ug per 1 ml, precision measuring 5ml of this solution and 5ml of internal standard solution, in the same 50ml measuring flask, dilute to the scale with methanol, shake, and measure with the same method. According to the internal standard method to calculate the ratio of Peak area, the drug amount of fine particles should not be less than 10% of the label amount.
- In addition to the uniformity of the delivered dose, the relevant provisions under inhaled formulations (General rule 0111) should be met.
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 (76:24) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 1500 based on the calculation of M pine peak of gas ploidy propionate, and the separation degree between beclomethasone dipropionate peak and internal standard substance peak shall be greater than 3.0.
- preparation of internal standard solution an appropriate amount of testosterone propionate was taken, dissolved in methanol and diluted to give a solution containing about 0.22mg per 1 ml, which was obtained by shaking.
- determination method: take 25 capsules (0. LMG) or 12 capsules (0.2mg)(equivalent to 2.5mg beclomethasone dipropionate), clear the capsules, pour the contents into a 100ml measuring flask, wash the inner wall of the capsule with methanol, wash with methanol, add an appropriate amount of methanol, shake beclomethasone dipropionate to dissolve, add 10ml internal standard solution, dilute to the scale with methanol, shake, filter, take the continued filtrate as the test solution, and inject it into the liquid chromatograph to record the chromatogram. Take about 25mg of the reference substance of beclomethasone dipropionate, weigh it accurately, and put it into a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take 10ml of the solution and 10ml of the internal standard solution, put it in the same 100ml measuring flask, dilute to the scale with methanol, shake well, same method determination. According to the internal standard method, the peak area ratio is calculated.
category
Same as beclomethasone dipropionate.
specification
(1)0.lmg (2)0.2mg
storage
keep in cool, dark and dry place.
Last Update：2022-01-01 11:35:24
Beclomethasone dipropionate - Beclometasone Dipropionate Cream
Authoritative Data Verified Data
This product contains beclomethasone dipropionate (C28H37ClO7) should be 90.0% ~ 110.0% of the label amount.
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).
containing the most measured
take an appropriate amount of this product (about 1.25mg equivalent to beclomethasone dipropionate), 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 beclomethasone dipropionate, and let it cool. According to the method of betamethasone dipropionate, add 5ml of internal standard solution with precision, dilute to scale with methanol, and shake well, cool in an ice bath for more than 2 hours, take it out and rapidly filter it. Take the filtrate and then put it to room temperature to be used as a test solution.
category
Same as beclomethasone dipropionate.
specification
10g:2.5mg
storage
sealed, stored in a cool place.
Last Update：2022-01-01 11:35:25
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Spot supply
Product Name: Betamethasone Dipropionate Impurity 5(Betamethasone Dipropionate EP Impurity E) Visit Supplier Webpage Request for quotationCAS: 5534-09-8
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Beclometasone Dipropionate Request for quotation
CAS: 5534-09-8
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 5534-09-8
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Beclomethasone Dipropionate Visit Supplier Webpage Request for quotationCAS: 5534-09-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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