phenobarbital
Phenobarbital
CAS: 50-06-6
Molecular Formula: C12H12N2O3
phenobarbital - Names and Identifiers
| Name | Phenobarbital |
| Synonyms | phenobarbital Phenobarbitone phenobarbital methanol solution 5-ethyl-5-phenylbarbituric acid phenobarbital free acid--dea schedule*iv item |
| CAS | 50-06-6 |
| EINECS | 200-007-0 |
| InChI | InChI=1/C12H12N2O3/c1-2-12(8-6-4-3-5-7-8)9(15)13-11(17)14-10(12)16/h3-7H,2H2,1H3,(H2,13,14,15,16,17) |
phenobarbital - Physico-chemical Properties
| Molecular Formula | C12H12N2O3 |
| Molar Mass | 232.24 |
| Melting Point | 174℃ |
| Water Solubility | <0.01 g/100 mL at 14℃ |
| Physical and Chemical Properties | White luster crystalline powder, odorless, slightly bitter taste. Melting point 174.5-178 °c. Slightly soluble in water, soluble in ethanol, ether, chloroform and alkaline solution |
| Use | Commonly used long-acting sedative hypnotic drugs, with sedative, hypnotic, antiepileptic and anticonvulsant effect, clinical for Anxiety restlessness, dysphoria, intractable insomnia, high fever, tetanus, it is used in combination with antipyretic and analgesic, and is also used for pre-anesthesia administration, grand mal epilepsy, etc. |
phenobarbital - 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 R61 - May cause harm to the unborn child |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| UN IDs | UN 2811 |
phenobarbital - Upstream Downstream Industry
| Raw Materials | 2-phenylacetamide |
phenobarbital - Standard
Authoritative Data Verified Data
This product is 5-ethyl-5-phenyl-2, 4,6 (1H,3H,5h)-pyrimidine trione. Calculated as dry product, containing C12H12N203 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
phenobarbital - Trait
Authoritative Data Verified Data
- This product is a white, shiny crystalline powder; Odorless; Saturated aqueous solution acidic reaction.
- This product is dissolved in ethanol or ether, slightly soluble in three gas methane, very slightly soluble in water; Dissolved in sodium hydroxide or sodium carbonate solution.
melting point
The melting point of this product (General rule 0612 first method) is 174.5~178°C.
Last Update：2022-01-01 13:33:26
phenobarbital - Differential diagnosis
Authoritative Data Verified Data
- take about 10 mg of this product, add 2 drops of sulfuric acid and about 5mg of sodium nitrite, mix, then turn orange yellow, then turn orange red.
- take about 50mg of this product, put it in a test tube, add 1ml of formaldehyde test solution, heat, boil, cool, slowly add 0.5ml of sulfuric acid along the tube wall to make two liquid layers, heated in a water bath, with rose-red interface.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 227).
- This product shows the identification reaction of malonylurea (General rule 0301).
Last Update：2022-01-01 13:33:27
phenobarbital - Exam
Authoritative Data Verified Data
acidity
take 0.20g of this product, add 10ml of water, boil and stir for 1 min, let cool, filter, take 5ml of filtrate, add 1 drop of methyl orange indicator solution, and do not show red. Clarity of ethanol solution take this product l.Og, add ethanol 5ml, heat reflux for 3 minutes, the solution should be clear.
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, silica gel bonded with octanosilane was used as filler, acetonitrile-water (25:75) was used as mobile phase, and the detection wavelength was 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 were accurately measured and injected into the human liquid chromatograph respectively, 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, 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 each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (1.0%).
neutral or alkaline substance
take this product l. Add 10ml of sodium hydroxide solution to the separating funnel, add 5ml of water and 25ml of diethyl ether, shake for 1 min, separate the ether layer, and wash with water for 3 times, 5ml each time, the ether solution was taken and filtered through a dry filter paper, and the filtrate was placed in an evaporation Dish having a constant weight of 105 ° C., evaporated to dryness, and dried at 105 ° C. For 1 hour. The residue left behind was not allowed to pass 3mg.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 13:33:28
phenobarbital - Content determination
Authoritative Data Verified Data
take about 0.2g of this product, weigh it accurately, add 40ml of methanol to dissolve it, then add 15ml of new 3% anhydrous sodium carbonate solution, and use potentiometric titration method (General rule 0701), with silver nitrate titration solution (O.lmol/L) titration. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 23.22mg of C12H12N203.
Last Update：2022-01-01 13:33:29
phenobarbital - Category
Authoritative Data Verified Data
sedative hypnotic drugs, anticonvulsants.
Last Update：2022-01-01 13:33:29
phenobarbital - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 13:33:29
phenobarbital - Phenobarbital tablets
Authoritative Data Verified Data
phenobarbital (C12H12N203) should be 93.0% ~ 107.0% of label children.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 0.lg of phenobarbital), add 10ml of anhydrous ethanol, fully shake, filter, and evaporate the filtrate on a water bath, the residue showed the same reaction according to the test of identification (1) and (4) under phenobarbital.
- 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.
examination
- relevant substances: take an appropriate amount of the fine powder of this product, add the mobile phase to dissolve and dilute to prepare a solution containing about 1 mg of phenobarbital per 1 ml, filter, and take the continued filtrate as the test solution; take 1 ml of precision, 200ml flask, diluted with mobile phase to the scale, shake, as a control solution. The determination was carried out according to the method for phenobarbital 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 1 times the area of the main peak of the control solution (1.0%)..
- Content uniformity take 1 tablet of this product, put it in a 50ml (30mg specification) or 25ml(15mg specification) measuring flask, add an appropriate amount of mobile phase, according to the method under the content determination item, from "20 minutes of ultrasound", according to the law to determine, should comply with the provisions (General 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 45 minutes, the solution is filtered, the appropriate amount of the filtrate is taken, and the amount of the filtrate is diluted quantitatively with boric acid gasification potassium buffer solution (pH 9.6) to make a solution containing about 5ug per 1 ml, and the solution is shaken; in addition, phenobarbital control substance was accurately weighed, dissolved and quantitatively diluted with the above buffer solution to prepare a solution containing 5ug per 1 ml. The absorbance of each of the above two Solutions was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (general), and the elution amount of each tablet was calculated. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using octanosilane bonded silica gel as filler; Acetonitrile-water (30:70) as mobile phase; The detection wavelength was 220nm. The number of theoretical plates shall not be less than 2000 calculated by phenobarbital peak, and the separation degree between phenobarbital peak and adjacent chromatographic peaks shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 30mg equivalent to phenobarbital), put it in a 50ml measuring flask, add an appropriate amount of mobile phase, dissolve phenobarbital by ultrasound for 20 minutes, let it cool, dilute to scale with mobile phase, shake well, filter, take 1ml filtrate accurately, put it in 10ml measuring flask, dilute to scale with mobile phase, shake, as a test solution, take 10ul injection into the liquid chromatograph, record the chromatogram; Take phenobarbital reference substance, precision weighing, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 60ug of phenobarbital per 1ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as phenobarbital.
specification
(l)15mg (2)30mg (3)50mg (4)100mg
storage
sealed storage.
Last Update：2022-01-01 13:33:30
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Raw Materials for phenobarbital