5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione
Phenobarbital Sodium
CAS: 57-30-7
Molecular Formula: C12H12N2O3.Na
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Names and Identifiers
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Physico-chemical Properties
| Molecular Formula | C12H12N2O3.Na |
| Molar Mass | 254.22 |
| Melting Point | 175°C |
| Boling Point | 384.7°C at 760 mmHg |
| Flash Point | 186.5°C |
| Water Solubility | >=10 g/100 mL at 20 ºC |
| Solubility | H2O: 1g/mL |
| Vapor Presure | 1.32E-06mmHg at 25°C |
| Merck | 13,7319 |
| BRN | 3802044 |
| PH | pH (100g/l, 25℃) : 9.0～11.0 |
| Use | Used as a sedative, anticonvulsant |
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | R25 - Toxic if swallowed R40 - Limited evidence of a carcinogenic effect R43 - May cause sensitization by skin contact |
| Safety Description | S22 - Do not breathe dust. 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.) |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | - |
| RTECS | CQ7000000 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 orally in rats: 660 mg/kg (Schaffarzick, Brown) |
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Standard
Authoritative Data Verified Data
This product is 5-ethyl-5-phenyl-2, 4,6 (1H,3H,5h)-pyrimidinetrione monosodium salt. Calculated as dry product, containing C12H11N2Na03 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Trait
Authoritative Data Verified Data
- This product is white crystalline particles or powder; No odor; Has the hygroscopicity.
- This product is very soluble in water, soluble in ethanol, almost insoluble in chloroform or ether.
Last Update：2022-01-01 13:33:31
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Differential diagnosis
Authoritative Data Verified Data
- take about 0.5g of this product, add 5ml of water to dissolve, add a slight excess of dilute hydrochloric acid, that is, precipitate a white crystalline precipitate, filter; Wash the precipitate with water, dry at 105°C, measured according to law (General rule 0612 ), the melting point was 174 to 178 ° C.; The remaining precipitate showed the same reaction according to the identification test under phenobarbital.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 228).
- identification reaction of sodium salt of this product (General rule 0301).
Last Update：2022-01-01 13:33:31
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Exam
Authoritative Data Verified Data
alkalinity
take l.Og of this product, Add 10ml of water to dissolve, and measure it according to law (General rule 0631). The pH value should be 9.5~10.5.
clarity of the solution
take l.Og of this product, add 10ml of water to dissolve, the solution should be clarified. (For injection)
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing lmg per lml as a test solution; Take 1ml for precision measurement and put it in a 200ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the high performance liquid chromatography (General rule 0512) test, using octyl silane bonded silica gel as filler, acetonitrile-water (25:75) as mobile phase, the detection wavelength is 220nm; the number of theoretical plates shall not be less than 2500 calculated by phenobarbital peak, and the separation degree between phenobarbital peak and adjacent impurity peaks shall meet the requirements. 5 u1 of each of the control solution and the test solution are injected into the liquid chromatograph respectively, and the chromatogram is 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, the single impurity peak area shall not be greater than the main peak area of the control solution (0.5%), and the sum of each impurity peak area shall not be greater than 2 times (1.0%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 150°C, weight loss shall not exceed 6.0% (General rule 0831).
Heavy metals
take 2.0g of this product, add 32ml of water to dissolve, slowly add 8ml of lmol/L hydrochloric acid solution, fully shake, stand for several minutes, filter; Take 20ml of filtrate, add 1 drop of phenolphthalein indicator solution and an appropriate amount of ammonia test solution until the solution is pink, add 2ml of acetate buffer (pH 3.5) and an appropriate amount of water to make 25ml, and check according to law (General rule 0821 method 1), heavy metals should not be more than 10 parts per million.
bacterial endotoxin
taking this product for inspection according to law (General rule 1143), the amount of endotoxin per 1 mg of phenobarbital sodium should be less than 0.50EU. (For injection)
sterile
take this product, Add 10ml of sterile water to dissolve, check according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 13:33:32
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Content determination
Authoritative Data Verified Data
This product is about 0.2g, precision weighing, according to the method of phenobarbital determination. Each 1 ml of silver nitrate titration solution (0.1 mol/ L) corresponds to 25.42mg of C12H11N2Na03.
Last Update：2022-01-01 13:33:32
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Category
Authoritative Data Verified Data
sedative hypnotic drugs, anticonvulsants.
Last Update：2022-01-01 13:33:33
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Storage
Authoritative Data Verified Data
under shading, sealed and preserved.
Last Update：2022-01-01 13:33:33
5-Ethyl-5-phenyl-2-sodiooxy-4,6(1H,5H)-pyrimidinedione - Phenobarbital sodium for injection
Authoritative Data Verified Data
This product is a sterile crystal or powder of sodium phenobarbital. The content of C12H11N2Na03 shall not be less than 98.5% based on the dry product; The content of phenobarbital sodium (C12H11N2Na03) shall be 93.0%-107.0% of the label amount based on the average loading.
trait
This product is white crystalline particles or powder.
identification
According to the identification test under the item of phenobarbital sodium, the same results were shown.
examination
- The alkalinity shall be checked according to the method under the item of phenobarbital sodium and shall comply with the regulations.
- take about 10mg of this product, put it in a 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, as a test solution; Take 1ml for precision measurement, set in a 200ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. According to the method of phenobarbital sodium related substances. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.5%), and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%).
- weight loss on drying this product shall be dried at 150°C to constant weight, and the weight loss shall not exceed 7.0% (General rule 0831).
- bacterial endotoxin this product, according to the law inspection (General 1143), per 1 mg of phenobarbital sodium containing endotoxin should be less than 0.50ELL
- sterile take this product, respectively, plus sterile water made per lml containing 50mg of the solution, according to the law (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The contents under the item of loading amount difference were taken and measured according to the method under the item of phenobarbital. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 25.42mg of C12H11N2NaO3.
category
with phenobarbital sodium.
specification
(l)50mg (2)100mg (3)200mg
storage
light shielding, closed storage.
Last Update：2022-01-01 13:33:34
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Spot supply
Product Name: Phenobarbital Sodium Salt Visit Supplier Webpage Request for quotationCAS: 57-30-7
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
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