dafil
nicardipine hydrochloride
CAS: 54527-84-3
Molecular Formula: C26H30ClN3O6
dafil - Names and Identifiers
| Name | nicardipine hydrochloride |
| Synonyms | dagan loxen dafil lincil Barizin Vasonas Dacarel nicardil rs-69216 perdipina bionicard Antagonyl Nicardipine HCl Naratriptan HCl Diphenidol hydrochloride nicardipine hydrochloride methyl 2-(benzyl-methyl-amino)ethyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride 2-(benzylmethylamino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylatemonohydrochloride 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid Methyl 2-[Methyl(phenylmethyl)amino]ethyl Ester Hydrochloride |
| CAS | 54527-84-3 |
| EINECS | 259-198-4 |
| InChI | InChI=1/C26H29N3O6.ClH/c1-17-22(25(30)34-4)24(20-11-8-12-21(15-20)29(32)33)23(18(2)27-17)26(31)35-14-13-28(3)16-19-9-6-5-7-10-19;/h5-12,15,24,27H,13-14,16H2,1-4H3;1H |
| InChIKey | AIKVCUNQWYTVTO-UHFFFAOYSA-N |
dafil - Physico-chemical Properties
| Molecular Formula | C26H30ClN3O6 |
| Molar Mass | 515.99 |
| Melting Point | 176-1780C |
| Boling Point | 603.4°C at 760 mmHg |
| Flash Point | 318.7°C |
| Solubility | Soluble in DMSO (1 mg/ml), water (slightly), methanol (50 mg/ml), chloroform (slightly) |
| Vapor Presure | 1.63E-14mmHg at 25°C |
| Appearance | Yellow solid |
| Color | yellow |
| Merck | 14,6495 |
| Storage Condition | 2-8°C |
| Stability | Stable for 1 year from date of purchase as supplied. Solutions in distilled water or ethanol may be stored at -20°C for up to 1 month. |
| Sensitive | Sensitive to light |
| MDL | MFCD00057327 |
| Use | Used as vasodilator |
dafil - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | 23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. |
| Safety Description | 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 | 3 |
| RTECS | US7972100 |
| HS Code | 2933399090 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 in male, female rats (mg/kg): 634, 557 orally; 18.1, 25.0 i.v.; in male, female mice: 634, 650 orally; 20.7, 19.9 i.v. (Odani, Sado) |
dafil - Standard
Authoritative Data Verified Data
This product is 2, 6-dimethyl-4-(3-nitrophenyl)-1, 4-dihydropyridine-3, 5-dicarboxylic acid, benzyl-N-methyl) amino] ethyl ester -5-methyl ester hydrochloride. The content of C26H29N306 • HC1 shall not be less than 98.5% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
dafil - Trait
Authoritative Data Verified Data
- This product is light yellow powder or yellow crystalline powder; Odorless, almost tasteless.
- This product is dissolved in methanol, slightly soluble in ethanol and chloroform, almost insoluble in water or ether; Dissolved in glacial acetic acid.
melting point
The melting point of this product (General rule 0612) is 179~185°C, and it is decomposed at the same time during melting.
absorption coefficient
take this product, precision weighing, add methanol to dissolve and quantitatively dilute to make a solution containing about 8ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 236nm, and the absorption coefficient was 507 to 539.
Last Update：2022-01-01 14:22:12
dafil - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 3ml of methanol to dissolve, add several drops of chromium ammonium thiocyanate test solution, and generate pink precipitate.
- take an appropriate amount of the solution under the item of absorption coefficient and measure it by ultraviolet-visible spectrophotometry (General rule 0401), which shows the maximum absorption at the wavelength of 236nm, there is minimal absorption at a wavelength of 219nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 334).
- take about 10 mg of this product, add 4ml of methanol to dissolve, and the solution shows the identification reaction of chloride (General rule 0301).
Last Update：2022-01-01 14:22:13
dafil - Exam
Authoritative Data Verified Data
Related substances
operation in the dark. Take this product, weigh it accurately, add an appropriate amount of methanol to dissolve it, and quantitatively dilute it with mobile phase to make a solution containing about 0.5mg per lml as a test solution; Take another 2, 6-dimethyl-4-(3-nitrophenyl)-3, 5-pyridinedicarboxylic acid -2-( N-benzyl-N-methyl) ethyl ester (impurity I) control, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 50ug per lml, take 2ml of precision measurement, put it in a 100ml measuring flask, add 1ml of test solution precisely, dilute to the scale with the mobile phase, shake, and serve as a control solution. Test according to high performance liquid chromatography (General 0512). Silica gel bonded with eighteen alkyl silane was used as the filler; Methanol -0.01 mol/L potassium dihydrogen phosphate solution (72:28) was used as the mobile phase; The detection wavelength was 236mn. Take appropriate amount of nicardipine hydrochloride reference substance and impurity I reference substance, add appropriate amount of methanol to dissolve, dilute with mobile phase to make mixed solution containing 0.5mg and lug in each 1 ml, inject 20ul into the liquid chromatograph and record the chromatogram. The resolution of nicardipine peak and impurity I peak should meet the requirements, they were injected into the liquid chromatograph, and the chromatogram was recorded to 4 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and shall not exceed 0.2%; the Peak area of other individual impurities shall not be greater than 0.5 times (0.5%) The Peak area of nicardipine in the control solution; The total amount of impurities shall not exceed 1.0%.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 14:22:14
dafil - Content determination
Authoritative Data Verified Data
take 0.4g of this product, precision weighing, add glacial acetic acid 20ml and Mercury acetate test solution 6ml, slightly warm to dissolve, cool, add crystal violet indicator solution 1 drop, with perchloric acid titration solution (O. 1 mol/L) titration to a blue color of the solution, and the results of the titration were corrected by a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol /L) corresponds to 51.60mg of C26H29N306. HCI.
Last Update：2022-01-01 14:22:14
dafil - Category
Authoritative Data Verified Data
vasodilators.
Last Update：2022-01-01 14:22:15
dafil - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 14:22:15
dafil - Nicardipine hydrochloride
Authoritative Data Verified Data
This product contains nicardipine hydrochloride (C26H29N306 • HCI) should be the label amount of 90.0% ~ 110.0%.
trait
This product is a yellowish tablet or sugar-coated tablet, after removing the coating, the microscopic yellow.
identification
- take an appropriate amount of fine powder of this product (about 20mg of nicardipine hydrochloride), add 8ml of methanol to dissolve nicardipine hydrochloride, filter, and divide the filtrate into two parts, the same reaction was shown according to the tests of (1) and (4) under nicardipine hydrochloride.
- in the chromatogram under the content determination, 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.
- take 1ml of the test solution under the content determination item, add methanol to 5ml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 236nm and a minimum absorption at a wavelength of 219nm.
examination
- the related substances were protected from light. Take an appropriate amount of fine powder (about 25mg of nicardipine hydrochloride) under the content determination item, weigh it accurately, put it in a 50ml measuring flask, add an appropriate amount of mobile phase, and sonicate it for about 15 minutes to dissolve nicardipine hydrochloride, cool, dilute to the scale with mobile phase, shake well, centrifuge for 10 minutes (3000 revolutions per minute), take the supernatant as the test solution; Take the reference substance of impurity I and weigh it accurately, add the mobile phase to dissolve and quantitatively dilute to make a solution containing about 50ug per lml, take 5ml with precision, put it in a 100ml measuring flask, add lml of human test solution with precision, dilute to the scale with mobile phase, as a control solution. The determination was carried out according to the method for related substances of nicardipine hydrochloride. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated by external standard method, and 0.5% of the labeled amount of nicardipine hydrochloride shall not be passed; the Peak area of other single impurities shall not be greater than that of nicardipine hydrochloride in the control solution (1.0%); The total amount of impurities shall not exceed 2.0%.
- Content uniformity protected from light. Take 1 tablet of this product, put it in mortar, grind it finely, add appropriate amount of mobile phase to grind it, and transfer it to 50ml measuring flask with the mobile phase, according to the method under the content determination item, from "ultrasonic about 15 minutes to dissolve nicardipine hydrochloride", according to the determination of content, should comply with the provisions (General 0941).
- 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 applicability test using eighteen alkyl silane bonded silica gel as filler; Methanol-O.Olmol/L potassium dihydrogen phosphate solution (72:28) as mobile phase; The detection wavelength was 236mn. The number of theoretical plates shall not be less than 1500 calculated by nicardipine peak, and the separation degree between nicardipine peak and adjacent impurity peaks shall meet the requirements.
- The assay was operated in the dark. Take 20 tablets of this product (sugar-coated tablets should be removed from the coating), Precision weighing, fine, precision weighing an appropriate amount (about equivalent to nicardipine hydrochloride lOmg ) , put it in a 50ml measuring flask, and add an appropriate amount of mobile phase, sonicate nicardipine hydrochloride for about 15 minutes, let it cool, dilute to scale with mobile phase, shake well, centrifuge for 10 minutes (3000 rpm), precisely measure 5ml of supernatant, put it in 25ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, take 20 u1 with precision, inject into liquid chromatograph, record chromatogram; Take nicardipine hydrochloride reference substance, precision weigh, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 40ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as nicardipine hydrochloride.
specification
lOmg
storage
light shielding, sealed storage.
Last Update：2022-01-01 14:22:16
dafil - Nicardipine Hydrochloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of nicardipine hydrochloride, containing nicardipine hydrochloride (C26H29N306 • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
This product is a light yellow green clear liquid.
identification
- take 4ml of this product, add a few drops of chromium ammonium thiocyanate test solution, which will generate pink precipitate.
- take 1ml of the test solution under the content determination item, add methanol to 5ml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 236nm and a minimum absorption at a wavelength of 219nm.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 3.5 to 5.0 (General 0631).
- the color of this product, compared with the yellow-green 5 standard colorimetric liquid (General Principles 0901 The first method), not deeper.
- the related substances were protected from light. Take 5 pieces of this product, mix well, take 5ml, put it in 10ml measuring flask, dilute it with mobile phase to scale, shake well, and use it as test solution, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 50ug per lml, take 5ml of precision measurement, put it in a 100ml measuring flask, add lml of test solution precisely, dilute to the scale with the mobile phase, shake, and serve as a control solution. The determination was carried out according to the method for related substances of nicardipine hydrochloride. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 0.5% of the labeled amount of nicardipine hydrochloride shall not be passed; the Peak area of other single impurities shall not be greater than that of nicardipine hydrochloride in the control solution (1.0%); The total amount of impurities shall not exceed 2.0%.
- appropriate amount of bacterial endotoxin should be taken and checked according to law (General rule 1143). The amount of endotoxin contained in nicardipine hydrochloride per 1 mg should be less than 5.0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-O.Olmol/L potassium dihydrogen phosphate solution (72:28) as mobile phase; The detection wavelength was 236nm. The number of theoretical plates shall not be less than 1500 calculated by nicardipine peak, and the separation degree between nicardipine peak and adjacent impurity peaks shall meet the requirements.
- The assay was operated in the dark. Take an appropriate amount of this product with precision, and quantitatively dilute it with mobile phase to make a solution containing about 50ug nicardipine hydrochloride per lml, as a sample solution, take 20ul with precision, and inject human liquid chromatograph, record chromatogram; Another nicardipine hydrochloride reference substance, precision weighing, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as nicardipine hydrochloride.
specification
(l)2ml:2mg (2)5ml:5mg (3)10ml:lOmg
storage
shade, close, and store in a cool place.
Last Update：2022-01-01 14:22:17
dafil - Nicardipine hydrochloride and glucose injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of nicardipine hydrochloride and glucose. Nicardipine hydrochloride (C26H29N3O6 • HCl) shall be 90.0% to 110.0% of the label; Glucose (C6H12O4 • H20) shall be 95.0% to 105.0% of the label.
trait
This product is a clear liquid from colorless to yellowish green.
identification
- take this product, slowly drop people slightly warm alkaline copper tartrate solution, that is, the formation of red cuprous oxide precipitate.
- 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
- the pH value should be 3.2 to 5.0 (General 0631).
- the color of this product, compared with the yellow-green No. 4 standard colorimetric liquid (General Principles 0901 first method), shall not be deeper.
- the related substances were protected from light. Take an appropriate amount of this product with precision, and dilute it with mobile phase to make a solution containing about 50ug nicardipine hydrochloride per 1 ml, as a sample solution; Take an appropriate amount with precision, A solution containing about 2ug of nicardipine hydrochloride per 1 ml was prepared by dilution with the mobile phase as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded to 4 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 0.5 times (2.0%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (4.0%).
- take an appropriate amount of heavy metal (about 3g of glucose), evaporate to about 20ml, let it cool, add 2ml of acetate buffer (pH 3.5) and water to make 25ml, inspection by law (General Principles 0821, law I), the content of heavy metals must not exceed 5 parts per million of the amount of glucose marked.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- nicardipine hydrochloride was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-O.Olmol/L potassium dihydrogen phosphate solution (72:28) as mobile phase; The detection wavelength was 236nm. The number of theoretical plates shall not be less than 1500 based on the calculation of nicardipine peak.
- The assay was operated in the dark. Take an appropriate amount of this product with precision, and quantitatively dilute it with mobile phase to make a solution containing about 5ug nicardipine hydrochloride per lml, as a test solution, take 20 u1 with precision, and inject human liquid chromatograph, record the chromatogram; Take another 50mg nicardipine hydrochloride reference, weigh it accurately, put it in a 100ml measuring flask, add 3ml methanol to dissolve it, dilute it with water to the scale, shake it well, take 10ml accurately, in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, and measure with the same method. According to the external standard method to calculate the peak area, that is.
- an appropriate amount of glucose was taken, and the optical rotation was measured at 25 ° C. According to the law (General rule 0621 ), and multiplied by 2.0852 to obtain a Weight (g) containing C6H1206 · H20 per of the test product.
category
Same as nicardipine hydrochloride.
specification
100ml: nicardipine hydrochloride lOmg with glucose 5.5g
storage
shade, close, and store in a cool place.
Last Update：2022-01-01 14:22:18
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Multiple SpecificationsSpot supply
Product Name: YC-93 Visit Supplier Webpage Request for quotationCAS: 54527-84-3
Tel: 609-228-6898
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Mobile: 609-228-6898
Spot supply
Product Name: Nicardipine hydrochloride Visit Supplier Webpage Request for quotationCAS: 54527-84-3
Tel: +86 0571-86722205
Email: sales@chinaskyrun.com
Mobile: +8618958170122
QQ: 2531159185
Wechat: chinaskyrun
Spot supply
Product Name: Nicardipine hydrochloride Visit Supplier Webpage Request for quotationCAS: 54527-84-3
Tel: +86-400-900-4166
Email: product@acmec-e.com
Mobile: +86-18621343501
QQ: 2881950922
Wechat: 18621343501
WhatsApp: +86-18621343501
Spot supply
Product Name: Nicardipine Hydrochloride Visit Supplier Webpage Request for quotationCAS: 54527-84-3
Tel: +86-18821248368
Email: Int06@meryer.com
Mobile: +86-18821248368
QQ: 495145328
WhatsApp: +86-18821248368
Multiple SpecificationsSpot supply
Product Name: Nicardipine hydrochloride Visit Supplier Webpage Request for quotationCAS: 54527-84-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
View History
dafil
4-氨基-5-溴-2-氯嘧啶
1-(5-tert-butyl-1H-pyrazol-3-yl)-N-methylmethanamine(SALTDATA: 1.45 HCl 0.2H2O 0.12NaCl)
戊二酰-L-苯丙氨酰-对硝基苯胺
(3-(4,4,5,5-Tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)methanol
but-1-en-3-ynylmethylether
3-Methyl-4-nitro-1H-pyrazole
t-Butyl Hypoiodite
1-ADAMANTYLZINC BROMIDE
2-乙酰基-5-碘噻吩
4-氨基-5-溴-2-氯嘧啶
1-(5-tert-butyl-1H-pyrazol-3-yl)-N-methylmethanamine(SALTDATA: 1.45 HCl 0.2H2O 0.12NaCl)
戊二酰-L-苯丙氨酰-对硝基苯胺
(3-(4,4,5,5-Tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)methanol
but-1-en-3-ynylmethylether
3-Methyl-4-nitro-1H-pyrazole
t-Butyl Hypoiodite
1-ADAMANTYLZINC BROMIDE
2-乙酰基-5-碘噻吩