BETAMETHASONE SODIUM PHOSPHATE
betamethasone 21-phosphate sodium
CAS: 151-73-5
Molecular Formula: C22H28FNa2O8P
BETAMETHASONE SODIUM PHOSPHATE - Names and Identifiers
BETAMETHASONE SODIUM PHOSPHATE - Physico-chemical Properties
| Molecular Formula | C22H28FNa2O8P |
| Molar Mass | 516.4 |
| Melting Point | 206-211°C |
| Boling Point | 669.6°C at 760 mmHg |
| Specific Rotation(α) | +98.0～+104.0°(D/20℃)(c=1,H2O) (calculated on the dehydrous basis) |
| Flash Point | 358.7°C |
| Solubility | Freely soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. |
| Vapor Presure | 8.62E-21mmHg at 25°C |
| Appearance | neat |
| Color | White to Off-White |
| Merck | 14,1180 |
| PH | 7.5～9.0(5g/l, 25℃) |
| Storage Condition | room temp |
| Stability | Hygroscopic |
| Use | Hormonal drugs, with anti-inflammatory effects |
BETAMETHASONE SODIUM PHOSPHATE - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 22 - Harmful if swallowed |
| Safety Description | 36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | TU4056500 |
| HS Code | 29372290 |
| Toxicity | LD50 orl-rat: 1877 mg/kg DRUGAY -,1075,90 |
BETAMETHASONE SODIUM PHOSPHATE - Standard
Authoritative Data Verified Data
This product is 16B-methyl-11B,17a, 21-trihydroxy-9a-fluorogestrol -1, 4-dien-3, 20-diketo-21-disodium phosphate salt. The content of C22H28FNa208P should be between 96.0% and 103.0% based on the water content.
Last Update：2024-01-02 23:10:35
BETAMETHASONE SODIUM PHOSPHATE - Trait
Authoritative Data Verified Data
- This product is white or off-white powder; Odorless or almost odorless; With hygroscopicity.
- This product is soluble in water, almost insoluble in acetone or chloroform.
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 it according to law (General rule 0621). The specific rotation should be 95 ° to 102 °.
Last Update：2022-01-01 15:37:48
BETAMETHASONE SODIUM PHOSPHATE - Differential diagnosis
Authoritative Data Verified Data
- take this product and betamethasone sodium phosphate reference, respectively, and methanol dissolved and diluted to prepare about 1 mg solution per 1 ml, according to thin layer chromatography (General 0502) test, draw 10 u1 of each of the above two solutions, respectively, on the same silica gel G thin layer plate, with dilute hydrochloric acid saturated butanol solution as the developing agent, expand, dry, spraying with sulfuric acid-methanol-nitric acid (10:10:1) and heating at 105°C for 10 minutes, the position and color of the main spot of the test solution should be the same as that of the control solution.
- take this product and dry it at 105°C for 3 hours. The infrared absorption spectrum should be consistent with the spectrum of the control (Spectrum set 659).
- take about 40mg of this product, put it in a porcelain crucible, add 2ml of sulfuric acid, heat at low temperature until the sulfuric acid vapor is removed, let it cool, add 0.5ml of nitric acid dropwise, continue to heat until the nitrogen oxide vapor is removed, burn at 500°C to make it completely Ash, let it cool, add 5ml of water to dissolve (if necessary, neutralize with ammonia test solution until it meets the litmus paper to show a neutral reaction), filtration, filtrate sodium salt and phosphate identification reaction (General 0301).
Last Update：2022-01-01 15:37:48
BETAMETHASONE SODIUM PHOSPHATE - Exam
Authoritative Data Verified Data
alkalinity
take this product, add water to dissolve and dilute the solution containing about 5mg per lml, according to the law (General 0631),pH value should be 7.0~9.0.
clarity and color of solution
take this product l.O g, after adding 20ml of fresh boiling cold water to dissolve, the solution shall be clear and colorless; In case of color development, it shall not be deeper in comparison with yellow or orange-yellow No. 2 Standard Colorimetric solution (General rule 0901 first method).
free phosphate precision scale
Take 20mg of this product and measure the absorbance according to the method under the item of dexamethasone sodium phosphate free phosphate. The absorbance of the test solution shall not be greater than that of the control solution.
Related substances
take this product, precision weighing, adding mobile phase to dissolve and dilute to make a solution containing about 2.5mg per lml as a test solution; Take lml for precision measurement and put it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, as a control solution; Take appropriate amount of betamethasone sodium phosphate and dexamethasone sodium phosphate control, dissolve and dilute with mobile phase to make a solution containing 40UG each in 1 ml, as a system suitability solution. According to the high performance liquid chromatography (General 0512) test, with eighteen alkyl silane bonded silica gel as filler, with potassium dihydrogen phosphate Hexylamine solution (take potassium dihydrogen acid 1.36g and Hexylamine 0.60g mixed, after 10 minutes, 185ml of water was added to dissolve)-acetonitrile (74:26) as a mobile phase, and the detection wavelength was 254nm. The system applicable solution 20u1 is injected into the liquid chromatograph, and the separation degree of betamethasone sodium phosphate peak and dexamethasone sodium phosphate peak should be greater than 2.0, and the separation degree of betamethasone sodium phosphate peak and adjacent impurity peak should meet the requirements. 20ul of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, no more than 1 impurity peak shall be found when the peak area is 0.5-1.0 times (1.0%-2.0%) of the main peak area of the control solution, other single impurity peak area shall not be greater than 0.5 times (1.0%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than 1.5 times (3.0%) of the main peak area of the control solution.
moisture
take 0.2g of this product, according to the determination of moisture (General rule 0832 first method 1), the water content shall not exceed 8.0%.
Last Update：2022-01-01 15:37:49
BETAMETHASONE SODIUM PHOSPHATE - 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 -0.05mol/L potassium dihydrogen phosphate solution (1:1) was used as the mobile phase; The detection wavelength was 254nm. The number of theoretical plates is not less than 2000 calculated as the betamethasone sodium phosphate peak.
assay
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 40ug per lml, take 20u1 injection of human liquid chromatography with precision, record the chromatogram; another betamethasone sodium phosphate reference substance was determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:37:50
BETAMETHASONE SODIUM PHOSPHATE - Category
Authoritative Data Verified Data
adrenocortical hormone drugs.
Last Update：2022-01-01 15:37:50
BETAMETHASONE SODIUM PHOSPHATE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:37:50
BETAMETHASONE SODIUM PHOSPHATE - Betamethasone sodium phosphate injection
Authoritative Data Verified Data
- This product is a sterilized aqueous solution of betamethasone sodium phosphate. The content of betamethasone sodium phosphate shall be 90.0% ~ 110.0% of the labeled amount based on betamethasone (C22H29F05).
- This product can add appropriate amount of stabilizer and cosolvent.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product, put it on a water bath to dry, take 2mg of residue, and add 2ml of sulfuric acid to dissolve it. The solution shows yellow color and turns brown after being left for a moment.
- 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 residue shows the identification reaction of the organic fluoride (General 0301).
examination
- the pH value should be 7.0 to 9.0 (General 0631).
- the specific rotation of this product is determined according to law (General rule 0621), and the specific rotation should be +88 ° to +108 °.
- Related substances take this product, add mobile phase to dissolve and dilute to prepare a solution containing about 1.315mg of betamethasone sodium phosphate per 1 ml, as a test solution; Take about 13mg of betamethasone reference, precision weighing, put it in a 10ml measuring flask, add appropriate amount of mobile phase to dissolve it, dilute it to the scale with the mobile phase, and shake it well. Take 2ml of the solution and 2ml of the test solution into 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, the detection wavelength was 241nm, 20ul of the control solution was injected into the liquid chromatograph, and the mobile phase flow rate was adjusted so that the retention time of betamethasone sodium phosphate peak was about 16 minutes, the number of theoretical plates shall not be less than 2000 according to the betamethasone sodium phosphate peak. The separation degree between betamethasone sodium phosphate peak and betamethasone peak shall be greater than 3.5, injected into the liquid chromatograph respectively, the chromatogram was recorded to 3 times of the retention time of the main component peak. The peaks before the relative retention time of 0.2 are subtracted from the chromatogram of the test solution. If there are impurity peaks with the same retention time as the betamethasone peak in the control solution, the peak area shall be calculated according to the external standard method, 2.6% of the labeled amount of betamethasone shall not be exceeded, and the peak area of other individual impurities shall not be greater than 1.5 times (3.0%) of the peak area of betamethasone sodium phosphate in the control solution, the sum of the peak areas of other impurities should not be greater than 2.5 times (5.0%) The Peak area of betamethasone sodium phosphate in the control solution.
- the bacterial endotoxin of this product should be taken and checked according to law (General rule 1143). The amount of endotoxin in each 1 mg betamethasone should be less than 22EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product (about 8mg equivalent to betamethasone), put it in a 50ml measuring flask, dilute it to the scale with water, shake it, take 5ml for precision measurement, put it in a 25ml measuring flask, dilute to scale with water, shake, as a test solution. According to betamethasone sodium phosphate content determination under the item of the method of determination, that is obtained.
category
with betamethasone sodium phosphate.
specification
- lml:2.63mg (equivalent to betamethasone 2mg)
- lml:5.26mg (equivalent to betamethasone 4mg)
storage
light shielding, closed storage.
Last Update：2022-01-01 15:37:51
Supplier List
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Product Name: Dexamethasone Sodium Phosphate Impurity 2（Dexamethasone Sodium Phosphate EP Impurity B） Visit Supplier Webpage Request for quotationCAS: 151-73-5
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Spot supply
Product Name: Dexamethasone Sodium Phosphate Impurity 2（Dexamethasone Sodium Phosphate EP Impurity B） Visit Supplier Webpage Request for quotationCAS: 151-73-5
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: betamethasone 21-phosphate sodium Request for quotation
CAS: 151-73-5
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: 151-73-5
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
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