DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT
dexamethasone 21-phosphate disodium salt
CAS: 2392-39-4;55203-24-2
Molecular Formula: C22H28FNa2O8P
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Names and Identifiers
| Name | dexamethasone 21-phosphate disodium salt |
| Synonyms | dexagro dexadreson decadronphosphate dexamethasonedisodiumphosphate disodiumdexamethasonephosphate Dexamethasone Phosphate Sodium Dexamethasone Sodium Phosphate Dexamethasone Phosphate Disodium disodiumsalt,(11beta,16alpha)-y) DEXAMETHASONE PHOSPHATE DISODIUM SALT dexamethasone 21-(disodium phosphate) dexamethasone 21-phosphate disodium salt DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT disodium (11beta,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate (9R,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one |
| CAS | 2392-39-4 55203-24-2 |
| EINECS | 219-243-0 |
| InChI | InChI=1/C22H29FO5/c1-12-8-16-15-5-4-13-9-14(25)6-7-19(13,2)21(15,23)17(26)10-20(16,3)22(12,28)18(27)11-24/h6-7,9,12,15-17,24,26,28H,4-5,8,10-11H2,1-3H3/t12-,15?,16?,17?,19?,20?,21+,22+/m1/s1 |
| InChIKey | PLCQGRYPOISRTQ-FCJDYXGNSA-L |
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Physico-chemical Properties
| Molecular Formula | C22H28FNa2O8P |
| Molar Mass | 516.4 |
| Density | 1.32g/cm3 |
| Melting Point | 233-235 °C |
| Boling Point | 568.2°C at 760 mmHg |
| Specific Rotation(α) | D +57° (water); D25 +74 ±4° (calcd on water-free and alcohol-free basis, concn of 10 mg/ml): USP XIX |
| Flash Point | 297.5°C |
| Water Solubility | Soluble in water. Slightly soluble in ethanol. Insoluble in dichloromethane. |
| Solubility | H2O: 50mg/mL, clear, faintly yellow |
| Vapor Presure | 2.81E-15mmHg at 25°C |
| Appearance | White to off-white powder |
| Color | white to off-white |
| Merck | 13,2960 |
| BRN | 6473066 |
| PH | pH(10g/l, 25℃) : 7.5～10.5 |
| Storage Condition | 2-8°C |
| Refractive Index | 1.591 |
| MDL | MFCD00079105 |
| Use | For the adrenal cortex hormone drugs, has anti-inflammatory, anti-toxic, anti-allergic effect |
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed R40 - Limited evidence of a carcinogenic effect R63 - Possible risk of harm to the unborn child |
| Safety Description | 36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. |
| WGK Germany | 3 |
| RTECS | TU4056000 |
| FLUKA BRAND F CODES | 3-10 |
| TSCA | Yes |
| HS Code | 2937220000 |
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Reference
| Reference Show more | 1. Yao Tao. Study on Differential Expression of Cyclic RNA in Hormonal Femoral Head Necrosis [D]. Anhui medical university, 2020. 2. Wu, Tao, et al. "Chronic glucocorticoid treatment induced circadian clock disorder led to lipid metabolism and gut microbiota alterations in rats." life sciences 192 (2018): 173-182.https://doi.org/10.1016/j.lfs. 2017.11.049 3. [IF=5.037] Tao Wu et al."Chronic glucocorticoid treatment induced circadian clock disorder leads to lipid metabolism and gut microbiota alterations in rats."Life Sci. 2018 Jan;192:173 4. [IF=2.877] Tao Wu et al."Timing of glucocorticoid administration determines severity of lipid metabolism and behavioral effects in rats."Chronobiol Int. 2017;34(1):78-92 |
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Standard
Authoritative Data Verified Data
This product is 16a-methyl-11B,17a,21-two basic-9a-the atmosphere of pregnancy -1,4-diene -3,20-diketo-21-phosphate disodium salt. The content of C22H28FNa208P shall be 97.0% to 102.0% based on the calculation of water-free and solvent-free substances.
Last Update：2024-01-02 23:10:35
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Trait
Authoritative Data Verified Data
- This product is white to yellowish powder; Odorless; With hygroscopicity.
- This product is dissolved in water or methanol, and is almost insoluble in acetone or ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General rule 0621). The specific rotation is 72 ° to 80 °.
Last Update：2022-01-01 11:43:50
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - 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 141).
- This product shows the identification reaction of organic fluoride (General rule 0301).
- take about 40mg of this product, add 2ml of sulfuric acid, slowly heat until white smoke occurs, Dropwise add 0.5ml of nitric acid, continue to heat until nitrogen oxide vapor is removed, cool, Dropwise add 2ml of water, then, the solution was slowly heated until white smoke occurred, and the solution was yellow in color. After cooling, 10ml of water was added dropwise, differential reaction of filtrate sodium salt with phosphate (General rule 0301).
Last Update：2022-01-01 11:43:51
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Exam
Authoritative Data Verified Data
alkalinity
take 0.lg of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 7.5~10.5.
clarity and color of solution
take 0.20g of this product and add 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method); If it is colored, comparison with yellow No. 2 Standard Colorimetric solution (General rule 0901 first method), not deeper.
free phosphate precision scale
Take 20mg of this product, put it in a 25ml measuring flask, add 15ml of water to dissolve it; Take another standard phosphate solution [take 105g of potassium dihydrogen phosphate dried at 0.35°C for 2 hours, put it in a ml measuring flask, add 10ml sulfuric acid solution (3-10) and appropriate amount of water to dissolve, dilute to the scale with water, shake well; Dilute 10 times when needed] 4.0ml, put another 25ml measuring flask, add 11ml water; precision Add ammonium molybdate sulfuric acid test solution 2.5ml and 1-amino -2-naphthol -4-sulfonic acid solution (take anhydrous sodium sulfite 5G, sodium bisulfite 0.7g and 1-amino -2-naphthol -4-sulfonic acid 1.5g, mix well, take this mixture g and add water 10ml to dissolve, if necessary, filter) 1ml, add water to the scale, shake well, and place at 20°C for 30-50 minutes. The absorbance was measured at a wavelength of 0401 mn according to UV-Vis spectrophotometry (general rule). The absorbance of the test solution shall not be greater than that of the control solution.
Related substances
take this product, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 1 mg per 1ml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake, as a control solution; Take the appropriate amount of dexamethasone control, precision weighing, and methanol dissolved and quantitatively diluted to make a solution containing about 1 mg per 1ml, take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it, and use it as a reference solution. According to the chromatographic conditions under the content determination item, take the sample solution accurately, the control solution and the reference solution were injected with 20 u1 respectively, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the dexamethasone peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.5%; other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of other impurity peak areas shall not be greater than 2 times (2.0%) of the main peak area of the control solution.
residual solvent
take this product about l. Add internal standard solution [take N-propanol and dilute with water to make 0.02%(ml/ml) solution], dissolve and dilute to the scale, shake, take 5ml of precision measurement, in the top empty bottle, sealed, as the test solution; Take methanol about 0.3g, ethanol about 0.5g and acetone about 0.5g, precision weighing, in a 100ml measuring flask, dilute to the scale with the above-mentioned internal standard solution, shake well, and precisely measure 1 ml. In a 10ml measuring flask, dilute to the scale with the above-mentioned internal standard solution, and shake well, 5ml was accurately measured, placed in a top empty bottle, sealed, and used as a reference solution. According to the test for determination of residual solvents (General rule 0861, Method 1), using a 6% cyanopropylphenyl-94% dimethylpolysiloxane capillary column with an initial temperature of 40°C, raise the temperature to 120°C at a rate of 5°C per minute for 1 minute, the equilibrium temperature of the headspace bottle is 90°C, the equilibrium time is 60 minutes, and the number of theoretical plates is not less than 10000 based on the N-propanol peak, the separation degree between peaks of each component shall meet the requirements. 1ml of the gas in the upper layer of the headspace bottle of the test solution and the reference solution were respectively measured and injected into the human gas chromatograph, and the chromatograms were recorded. According to the internal standard method to calculate the peak area, methanol, ethanol and acetone residues should be in accordance with the provisions.
moisture
take an appropriate amount of this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 15.0%.
Last Update：2022-01-01 11:43:52
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane as filler; Triethylamine solution (take 7.5 of triethylamine, dilute to 1000ml with water, adjust pH to 3.0±0.05 with phosphoric acid)-methanol-acetonitrile (55:40:5) as mobile phase; The detection wavelength was 242nm. Dexamethasone sodium phosphate was taken, dissolved and diluted with mobile phase to make a solution containing about 1 mg per 1 ml, and dexamethasone was additionally taken, methanolic solution was added and diluted to make a solution containing about 1 mg per 1 ml. The appropriate amount of the above two solutions is accurately measured respectively, and the mixed solution containing about 10ug in each lml is diluted by adding mobile phase, and 20u1 is injected into the liquid chromatograph to record the chromatogram, the number of theoretical plates shall not be less than 7000 according to the calculation of dexamethasone sodium phosphate peak, and the separation degree of dexamethasone sodium phosphate peak and dexamethasone peak shall be greater than 4.4.
assay
take about 20mg of this product, precision weighing, put it in 50ml measuring flask, add water to dissolve and dilute to the scale, shake, take appropriate amount of precision, the solution containing about 40ug per 1 ml was prepared by quantitative dilution with mobile phase, and was used as the test solution. 20PL was injected into the human liquid chromatograph with precise quantity, and the chromatogram was recorded. Calculated by multiplying the peak area by 1.0931 according to the external standard method.
Last Update：2022-01-01 11:43:53
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Category
Authoritative Data Verified Data
adrenocortical hormone drugs.
Last Update：2022-01-01 11:43:53
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Storage
Authoritative Data Verified Data
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 11:43:53
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Dexamethasone sodium phosphate injection
Authoritative Data Verified Data
- This product is a sterile aqueous solution of dexamethasone sodium phosphate. Dexamethasone-containing sodium phosphate (C22H28FNa208P) shall be between 90.0% and 110.0% of the labeled amount.
- This product can add appropriate amount of stabilizer and cosolvent.
trait
This product is a clear colorless 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
- the pH value should be 7.0 to 8.5 (General 0631).
- appropriate amount of related substances should be taken and quantitatively diluted with mobile phase to make a solution containing about 0.5mg of dexamethasone sodium phosphate per 1 ml, which should be used as the test solution. Take 1 ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake, as a control solution; Take the appropriate amount of dexamethasone control, precision weighing, and methanol dissolved and quantitatively diluted to make a solution containing about 0.5mg per 1 ml, accurately measure 1 ml, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as a reference solution. Take about 10mg of dexamethasone sodium phosphate and put it in a 10ml measuring flask, add sodium bisulfite solution (weigh about 15g of sodium bisulfite and put it in a 100ml measuring flask), dilute with water to the mark, adjust pH value to 30% with 8.0 sodium hydroxide solution)-3ml, sonicate to dissolve, dilute to the mark with fresh boiling water (adjust the pH to 30% with 8.0 sodium hydroxide solution), heat in a water bath for 30 minutes, and let to cool as a positioning solution for impurity I. The column temperature was 40 ° C. Under the chromatographic conditions under the dexamethasone sodium phosphate related substances (Thermo BDS HYPERSIL C18,4.6mm × 250mm, 5um or column with equivalent separation efficiency). The positioning solution 20u1 of the impurity I is injected into the human liquid chromatograph, and the flow rate is adjusted so that the retention time of the dexamethasone sodium phosphate peak is 20 to 25 minutes, and the relative retention time of the impurity I is about 0.3. Then the sample solution, the control solution and the reference solution of 20 u1 were injected into the liquid chromatograph respectively, and the chromatograms were recorded. In the chromatogram of the test solution, if there is a peak consistent with the retention time of dexamethasone peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and 0.5% of the labeled amount shall not be exceeded; if there is a chromatographic peak consistent with the retention time of impurity I peak in the chromatogram of impurity I solution, the corrected peak area (multiplied by the correction factor 1.41) shall not be greater than the main peak area of the control solution (1.0% ) ; other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, the sum of the peak area of impurity I and the peak area of other impurities after correction shall not be more than 2 times (2.0%) of the main peak area of the control solution. The excipient peak before the relative retention time of dexamethasone sodium phosphate peak in the chromatogram of the test solution is 0.2 is negligible, and the chromatographic peak which is less than 0.05 times of the main peak area of the control solution is negligible (0.05%).
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg dexamethasone sodium phosphate containing endotoxin amount should be less than 1.2EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product with precision and dilute it quantitatively with water to make a solution containing 0.4mg of dexamethasone sodium phosphate per 1 ml. Take 5ml with precision and put it in a 50ml measuring flask, dilute it to the scale with mobile phase, shake, according to dexamethasone sodium phosphate content determination method under the item, that is obtained.
category
sodium phosphate with dexamethasone.
specification
(l)lml:lmg (2)lml:2mg (3)lml:5mg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:43:54
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT - Cimefon sodium phosphate eye drops
Authoritative Data Verified Data
This product contains dexamethasone sodium phosphate (C22H28FNa208P) should be the label amount of 90.0% ~ 110.0%.
trait
This product is a clear colorless 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
- the pH value should be 7.0 to 8.5 (General 0631).
- osmolarity as measured by the osmolarity measurement method (General 0632), The osmolarity ratio should be 0.9 to 1.1.
- others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
take 10ml of this product with precision, put it in a 25ml measuring flask, dilute it to the scale with water, shake it well, take 10ml with precision, put it in a 25ml measuring flask, dilute it to the scale with mobile phase, shake, as a test solution, according to the method under the dexamethasone sodium phosphate content determination, obtained.
category
sodium phosphate with dexamethasone.
specification
5ml:1.25mg
storage
sealed and kept in a cool dark place.
Last Update：2022-01-01 11:43:55
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Mobile: +86-18621343501
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Product Name: dexamethasone 21-phosphate disodium salt Request for quotationCAS: 2392-39-4
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
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View History
DEXAMETHASONE 21-PHOSPHATE DISODIUM SALT
CALCIUM BENZOATE, REAGENTCALCIUM BENZOATE, REAGENTCALCIUM BENZOATE, REAGENTCALCIUM BENZOATE, REAGENT
6-甲基-2-甲硫基-4-氯嘧啶
桑辛素(桑根皮素,桑根白皮素)
1-氨基-1-环戊基甲醇
Sodium taurochenodeoxycholate
2-氯甲基-3-氟吡啶
4-氨基-6-氯-5-氨基嘧啶
1-Iodooctane (stabilized with Copper chip)
2-氨基-5-二乙氨基戊烷
CALCIUM BENZOATE, REAGENTCALCIUM BENZOATE, REAGENTCALCIUM BENZOATE, REAGENTCALCIUM BENZOATE, REAGENT
6-甲基-2-甲硫基-4-氯嘧啶
桑辛素(桑根皮素,桑根白皮素)
1-氨基-1-环戊基甲醇
Sodium taurochenodeoxycholate
2-氯甲基-3-氟吡啶
4-氨基-6-氯-5-氨基嘧啶
1-Iodooctane (stabilized with Copper chip)
2-氨基-5-二乙氨基戊烷