Name | Carbamazepine-d10 |
Synonyms | CARBAMAZEPIN carbamazepine CARBAMAZEPINE Carbamazepine-d10 CarbaMazepine-13C6 Carbamazepine solution Oxcarbazepine IMpurity A 5-carbamoyl-5h-dibenz[b,f]azepine 5h-dibenz[b,f]azepine-5-carboxamide 5H-dibenzo[b,f]azepine-5-carboxamide |
CAS | 298-46-4 |
EINECS | 206-062-7 |
InChI | InChI=1/C15H12N2O/c16-15(18)17-13-7-3-1-5-11(13)9-10-12-6-2-4-8-14(12)17/h1-10H,(H2,16,18) |
Molecular Formula | C15H12N2O |
Molar Mass | 236.27 |
Density | 1.1099 (rough estimate) |
Melting Point | 191-192 °C (lit.) |
Boling Point | 378.73°C (rough estimate) |
Flash Point | 9℃ |
Water Solubility | pract. insoluble |
Solubility | Soluble in ethanol, acetone, propylene glycol, insoluble in water. |
Vapor Presure | 5.78E-07mmHg at 25°C |
Appearance | White or white-like crystalline powder. |
Color | Almost white |
Merck | 14,1781 |
pKa | 13.94±0.20(Predicted) |
Storage Condition | 2-8°C |
Refractive Index | 1.5906 (estimate) |
MDL | MFCD00005073 |
Physical and Chemical Properties | Melting point 189-192°C water-soluble pract. insoluble |
Use | Anticonvulsants for grand mal epilepsy and psychomotor epilepsy, also for trigeminal neuralgia |
Risk Codes | R42/43 - May cause sensitization by inhalation and skin contact. R22 - Harmful if swallowed R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
Safety Description | S37 - Wear suitable gloves. S24 - Avoid contact with skin. S22 - Do not breathe dust. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S36 - Wear suitable protective clothing. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. |
UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
WGK Germany | 2 |
RTECS | HN8225000 |
HS Code | 29339900 |
Toxicity | LD50 orally in mice, rats: 3750, 4025 mg/kg (Stenger, Roulet) |
Reference Show more | 1. Li Rongrong, Zhao Di, Li monmeng, Shu Shengnan, Wang peyang, Li Huanru, Feng Suxiang. Metabolites of main components in Fritillaria Thunbergii and pericarpium citri reticulatae in rats based on UHPLC-Q Exactive-Orbitrap high resolution mass spectrometry [J]. Journal of Pharmaceutical Analysis, 2020, v.40(08):86-97. 2. Sun Jiangyan, Liu Chongchong, Yuan Siyuan, Wang Xiaohui, Liu Jinmin. Effects of chaibei Zhixian decoction and its main blood component saikosaponin a on the brain distribution of carbamazepine in epilepsy model rats [J]. Journal of Traditional Chinese Medicine, 2019,60(08):689-695. 3. Liu Chongchong, Sun Jiangyan, Dong Xiaoke, Wang Kaiyue, Li Zhonghao, Wu Min, Li Lili, Liu Jinmin. Effect and mechanism of chaibei Zhixian decoction and its absorption component beimine A on carbamazepine content in rat brain [J]. Chinese Journal of Experimental prescriptions, 2019,25(19):32-38. 4. Li Rongrong, Zhao Di, Li monmeng, Shu Shengnan, Wang peyang, Li Huanru, Feng Suxiang. Metabolites of main components in Fritillaria Thunbergii and pericarpium citri reticulatae in rats based on UHPLC-Q Exactive-Orbitrap high resolution mass spectrometry [J]. Journal of Pharmaceutical Analysis, 2020,40(08):1413-1424. 5. [IF = 1.902] Yining Zhao et al."Simultaneous quantification of 23 bioactive compounds in Tanreqing capsule by high-performance liquid chromatography." Biomed Chromatogr. 2019 Jul;33(7):e4531 6. [IF = 6.639] Fanchao Meng et al.. "Cancers. Oct 2019; 11(10):1571 7. [IF=6.4] Jing Zhao et al."Natural Nano-Drug Delivery System in Coptidis Rhizoma Extract with Modified Berberine Hydrochloride Pharmacokinetics."Int J Nanomed. 2021; 16: 6297-6311 8. [IF=5.81] Zhao Jing et al."Intra-Herb Interactions: Primary Metabolites in Coptidis Rhizoma Extract Improved the Pharmacokinetics of Oral Berberine Hydrochloride in Mice."Front Pharmacol. 2021 Jun;0:1426 9. [IF=1.902] Tingting Liu et al."Pharmacokinetic-pharmacodynamic modeling analysis and anti-inflammatory effect of Wangbi capsule in the treatment of adjuvant-induced arthritis."Biomed Chromatogr. 2021 Jul;35(7):e5101 10. [IF=0.837] Shi Xiangjun et al."Preparation and In Vitro/Vivo Evaluation of New Celecoxib Solid Dispersions with Co-Carrier Containing Aerosil and Poloxamer 188."Pharm Chem J . 2021 Jan;54(10):1033-1039 11. [IF=7.312] Yunyun Li et al."Mass transfer enhancement for rapid, selective extraction of pharmaceuticals by enlarging the microporous on isostructural zeolitic imidazolate Framework-8."SEPARATION AND PURIFICATION TECHNOLOGY. 2022 Jul;293:121102 |
This product is 5h-dibenzo [6,f] Nitrogen weed-5-carboxamide. The content of C15H12N20 shall be 98.0% ~ 102.0% calculated as dry product.
The melting point of this product (General 0612) is 189~193°C.
take L. 0g of this product, add water 20ml, stir for 15 minutes, filter, take the filtrate 10ml, add phenolphthalein indicator solution 1 drop, with sodium hydroxide titration solution (0.Olmol/L) titration, consumption of sodium hydroxide titration solution (0.Olmol/L) should not pass 0.50; Add 3 drops of Methyl red indicator solution, and use hydrochloric acid titration solution (0.Olmol/L) titration, consumption of hydrochloric acid titration solution (0.Olmol/L) should not exceed 1.0 mL.
take this product l. Add 100ml of water, boil, cool, filter, take 50ml of filtrate, check according to law (General rule 0801), and standard sodium nitride solution 7.0ml of the control solution should not be more concentrated (0.014%).
take about 50mg of this product, put it in a 50ml measuring flask, add 25ml of methanol to dissolve it, dilute it with water to scale, shake it well, and use it as a test solution, place in 50rnl measuring flask, dilute to scale with methanol-water (1:1), shake well, take 5ml accurately, put in 50ml measuring flask, use methanol-water (1:1) dilute to the scale, shake, as a control solution. According to the chromatographic condition test under the content determination item, take the control solution and the test solution with 20 u1 respectively, and inject the human liquid chromatograph respectively, the chromatogram was recorded to 6 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 (0.2% ) , and the sum of each impurity peak area shall not be greater than 2.5 times (0.5%) of the area of the main peak of the control solution..
take this product, dry at 105°C for 2 hours, loss of weight shall not exceed 0.5% (General rule 0831).
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
The residue left under the item of burning and flooding shall be inspected according to law (general law 0821, Law II) and shall not contain more than 10 parts per million of heavy metals.
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with cyanopropylsilane as filler; Methanol-tetrahydrofuran-water (120:30:850) as the mobile phase (1000ml containing 0.2ml formic acid and 0.5ml triethylamine detection wavelength of 230nm carbamazepine control sample about 25mg, 100ml flask, plus methylol-water (1:1)) dissolve the solution and dilute to the scale, shake well, take 20ul injection liquid chromatograph, and calculate the number of theoretical plates according to carbamazepine peak to be not less than 5000. The separation degree of carbamazepine peak and adjacent impurity peaks should meet the requirements.
take about 50mg of this product, weigh it accurately, put it in a 50ml measuring flask, add methylated 25ml, shake to dissolve, dilute it with water to the scale, shake it well, take 5ml with precision, dilute the flask with methanol-water (1:1) solution to scale, shake well, inject 20ul into human liquid chromatograph with precision, record the chromatogram, and take the reference substance of carbamazepine, same method determination. According to the external standard method to calculate the peak area, that is.
antiepileptic drugs.
light shielding, sealed storage.
This product contains carbamazepine (C15H12N20) should be 95.0% to 105.0% of the label.
This product is white tablet.
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about equivalent to 50mg of carbamazepine), put it in a 50ml measuring flask, add about 25ml of methanol, shake to dissolve carbamazepine, dilute to the scale with water, shake well, filter, Take 5ml of continuous filtrate precisely, put it in 25ml measuring flask, use methanol-water (1:1) dilute to the scale, shake, as a test solution. According to the determination of carbamazepine content under the item of the method of determination, that is obtained.
Same as carbamazepine.
(1)0.lg (2)0.2g
This product contains carbamazepine (C15H12N20) should be 95.0% to 105.0% of the label.
The content of this product is white or white powder.
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 50mg equivalent to carbamazepine) accurately, put it in a 50ml measuring flask, and add about 25ml of methanol, shake to dissolve carbamazepine, dilute to the scale with water, shake well, filter, Take 5ml of continuous filtrate precisely, put it in 25ml measuring flask, use fermentation-water (1:1) the solution was diluted to the scale and shaken to a test solution. According to the determination of carbamazepine content under the item of the method of determination, that is obtained.
Same as carbamazepine.
0.2g
light shielding, sealed storage.