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 |
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) |
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%.
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.
take l.Og of this product, add 10ml of water to dissolve, the solution should be clarified. (For injection)
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.
take this product, dry to constant weight at 150°C, weight loss shall not exceed 6.0% (General rule 0831).
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.
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)
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)
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.
sedative hypnotic drugs, anticonvulsants.
under shading, sealed and preserved.
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.
This product is white crystalline particles or powder.
According to the identification test under the item of phenobarbital sodium, the same results were shown.
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.
with phenobarbital sodium.
(l)50mg (2)100mg (3)200mg
light shielding, closed storage.