Chemical Properties:
Package: Bottle, Aluminium foil bag, 25kg/Cardboard Drum, or according to customer's requirement. Storage Condition: Store in a tightly closed container. Store in a cool, dry (2~8℃) and well-ventilated warehouse away from incompatible substances. Protect from light and moisture. Shipping: Deliver to worldwide by air, by FedEx / DHL Express. Provide fast and reliable delivery. Shanghai Ruifu Chemical Co., Ltd. is the leading manufacturer of Carvedilol (CAS: 72956-09-03) with high quality. Ruifu Chemical can provide worldwide delivery, competitive price, excellent service, small and bulk quantities available. Purchase Carvedilol, Please contact: alvin@ruifuchem.comDescription:
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| Chemical Name | Carvedilol |
| Synonyms | 1-(9H-Carbazol-4-yloxy)-3-[[2-(2-Methoxyphenoxy)ethyl]amino]-2-Propanol; Artist; Cadilan; Carca; Cardivas; Carloc; Carvas; Carvedilol; Carvediol; Coreg; DQ 2466; Dilatrend; Dimitone; Eucardic; Korvasan; Kredex; Querto; Talliton; BM-14190 |
| Stock Status | In Stock, GMP Commercial |
| CAS Number | 72956-09-3 |
| Molecular Formula | C24H26N2O4 |
| Molecular Weight | 406.48 g/mol |
| Melting Point | 115.0 to 119.0℃ |
| Density | 1.250±0.06 g/cm3 |
| Solubility in Water | Insoluble in Water |
| Solubility | Soluble in Methanol. Slightly Soluble in Ethanol, Ether |
| Storage Temp. | Cool & Dry Place (2~8℃) |
| COA & MSDS | Available |
| Brand | Ruifu Chemical |
Advantages:
How to Purchase? Please contact Dr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com 15 Years Experience? We have more than 15 years of experience in the manufacture and export of a wide range of high quality pharmaceutical intermediates or fine chemicals. Main Markets? Sell to domestic market, North America, Europe, India, Korea, Japanese, Australia, etc. Advantages? Superior quality, affordable price, professional services and technical support, fast delivery. Quality Assurance? Strict quality control system. Professional equipment for analysis include NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, K.F, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, etc. Samples? Most products provide free samples for quality evaluation, shipping cost should be paid by customers. Factory Audit? Factory audit welcome. Please make an appointment in advance. MOQ? No MOQ. Small order is acceptable. Delivery Time? If within stock, three days delivery guaranteed. Transportation? By Express (FedEx, DHL), by Air, by Sea. Documents? After sales service: COA, MOA, ROS, MSDS, etc. can be provided. Custom Synthesis? Can provide custom synthesis services to best fit your research needs. Payment Terms? Proforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T (Telex Transfer), PayPal, Western Union, etc.FAQ:
Stable Supply: Maintain reasonable stock
Professional Service: One stop purchasing service
Technical Support: Technology solution available
Custom Synthesis Service: Ranged from grams to kilos
Fast Delivery: If within stock, three days delivery guaranteed
High Quality: Established a complete quality assurance system
Sufficient Capacity: Sufficient facilities and technicians
OEM Package: Custom package and label available
Specifications:
| Items | Inspection Standards | Results |
| Appearance | White Crystalline Powder | Complies |
| Loss on Drying | ≤0.50% (105℃ for 3 h) | 0.25% |
| Residue on Ignition | ≤0.10% | 0.07% |
| Related Substances | ||
| Total Impurities | ≤0.50% | Complies |
| Impurity A | ≤0.20% | Complies |
| Impurity C | ≤0.02% | Complies |
| Any Other Individual Impurity | ≤0.10% | Complies |
| Heavy Metals (Pb) | ≤10ppm | <10ppm |
| Purity / Analysis Method | >99.0% (HPLC) | 99.72% |
| Infrared Spectrum | Conforms to Structure | Complies |
| Conclusion | The product has been tested & complies with the specifications | |
72956-09-3 - Safety Information:
72956-09-3 - Application:
Hazard Codes N,Xn Risk Statements 51/53-36/37/38-20/21/22 Safety Statements 61-36-26 RIDADR UN 3077 9/PG 3 WGK Germany 3 RTECS UA8670000 HazardClass IRRITANT PackingGroup III Hazardous Substances Data 72956-09-3(Hazardous Substances Data) Toxicity LD50 oral in dog: > 1gm/kgCarvedilol (CAS: 72956-09-03) is a vasodilating beta-blocker useful in the treatment of hypertension and angina pectoris. In addition to lowering blood pressure, carvedilol decreases total vascular resistance without the reflex tachycardia usually occurring with vasodilators. It is reported to be well tolerated with renal sparing effects. Carvedilol was first launched in Belgium in 1985. This product can block alpha and beta receptors, no intrinsic activity, in high concentrations of fashion with calcium antagonism. It has a strong effect of blocking beta receptors, which can expand blood vessels, reduce peripheral resistance and lower blood pressure, and has little effect on cardiac output and heart rate. Clinical can be used for primary hypertension and angina pectoris.72956-09-3 - USP 35 Standard:
DEFINITION
Carvedilol contains NLT 98.0% and NMT 102.0% of C24H26N2O4, calculated on the dried basis.
IDENTIFICATION
• A. Infrared Absorption <197K>
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Buffer: 2.72 g/L of monobasic potassium phosphate. Adjust with dilute phosphoric acid to a pH of 2.0.
Mobile phase: Acetonitrile and Buffer (31:69)
System suitability solution: 0.05 mg/mL each of USP Carvedilol RS and USP Carvedilol Related Compound A RS in Mobile phase
Standard solution: 0.04 mg/mL of USP Carvedilol RS in Mobile phase
Sample solution: 0.04 mg/mL of Carvedilol in Mobile phase
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 240 nm
Column: 4.6-mm × 15-cm; 5-µm packing L7
Column temperature: 55℃
Flow rate: 1 mL/min
Run time: 60 min
Injection size: 10 µL
System suitability
Sample: System suitability solution
Suitability requirements
Resolution: NLT 4.0 between carvedilol and carvedilol related compound A
Tailing factor: NMT 1.5 for the carvedilol peak
Relative standard deviation: NMT 2%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of carvedilol (C24H26N2O4) in the portion of the sample taken:
Result = (rU/rS) × (CS/CU) × 100
| rU= | peak response of carvedilol from the Sample solution |
| rS= | peak response of carvedilol from the Standard solution |
| CS= | concentration of carvedilol in the Standard solution (mg/mL) |
| CU= | concentration of Carvedilol in the Sample solution (mg/mL) |
Acceptance criteria: 98.0%-102.0% on the dried basis
IMPURITIES
• Residue on Ignition <281>: NMT 0.1% from 1 g
• Heavy Metals, Method II <231>: NMT 10 ppm
• Organic Impurities, Procedure 1: [Note-On the basis of the impurities present, perform either Organic Impurities, Procedure 1 or Organic Impurities, Procedure 2. Organic Impurities, Procedure 2 is recommended when carvedilol related compound F is a potential impurity.]
Buffer and Mobile phase: Prepare as directed in the Assay.
System suitability solution: 0.05 mg/mL each of USP Carvedilol RS and USP Carvedilol Related Compound C RS in Mobile phase
Standard solution: 1 µg/mL each of USP Carvedilol RS, USP Carvedilol Related Compound A RS, USP Carvedilol Related Compound B RS, USP Carvedilol Related Compound D RS, and USP Carvedilol Related Compound E RS, and 0.2 µg/mL of USP Carvedilol Related Compound C RS in Mobile phase
Sample solution: 1 mg/mL of Carvedilol in Mobile phase
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: Dual wavelength, UV 220 and 240 nm. Use 220 nm for quantitating carvedilol related compound E, and use 240 nm for carvedilol and all other related compounds.
Column: 4.6-mm × 15-cm; 5-µm packing L7
Column temperature: 55℃
Flow rate: 1 mL/min
Injection size: 20 µL
System suitability
Sample: System suitability solution
Suitability requirements
Resolution: NLT 17 between carvedilol and carvedilol related compound C
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of carvedilol related compound A, carvedilol related compound B, carvedilol related compound C, carvedilol related compound D, carvedilol related compound E, and any other individual impurity in the portion of Carvedilol taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | peak response of the corresponding related compound or any other impurity from the Sample solution |
| rS | = | peak response of the corresponding related compound from the Standard solution. To calculate the percentage of any other individual impurity use the peak response of carvedilol. |
| CS | = | concentration of the corresponding related compound in the Standard solution (mg/mL). To calculate the percentage of any other impurities for CS, use the concentration of USP Carvedilol RS. |
| CU | = | concentration of Carvedilol in the Sample solution (mg/mL) |
Acceptance criteria: See Table 1.
Table 1
| Name | Relative Retention Time | Acceptance Criteria, NMT (%) | |
| Carvedilol related compound Ea | 0.35 | 0.1 | |
| Carvedilol related compound Ab | 0.52 | 0.1 | |
| Carvedilol bisalkylpyrocatechol derivative (if present)c | 0.70 | 0.15 | |
| Carvedilol | 1.0 | — | |
| Carvedilol related compound Cd | 3.6 | 0.02 | |
| Carvedilol related compound De | 5.0 | 0.1 | |
| Carvedilol related compound Bf | 8.5 | 0.1 | |
| Any other individual impurity | - | 0.10 | |
| Total impurities | - | 0.5g | |
| a 2-(2-Methoxyphenoxy)ethyl amine. b 1-(4-(2-Hydroxy-3-(2-(2-methoxyphenoxy)ethylamino)propoxy)-9H-carbazol-9-yl)-3-(2-(2-methoxyphenoxy)ethylamino) propan-2-ol. c 3,3¢-{2,2¢-[1,2-Phenylenebis(oxy)]bis(ethane-2,1-diyl)}bis(azanediyl)bis(1-(9H-carbazol-4-yloxy)propan-2-ol). d 1-(9H-Carbazol-4-yloxy)-3-(benzyl(2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol. e 4-(Oxiran-2-ylmethoxy)-9H-carbazole. f 3,3¢-(2-(2-Methoxyphenoxy)ethylazanediyl)bis(1-(9H-carbazol-4-yloxy)propan-2-ol). g Disregard any impurity less than 0.01%. | |||
• Organic Impurities, Procedure 2
Solution A: Acetonitrile and trifluoroacetic acid (100:0.1)
Solution B: Trifluoroacetic acid and water (0.1:100)
Diluent: Acetonitrile, trifluoroacetic acid, and water (22:0.1:78)
Mobile phase: See Table 2
Table 2
| Time (min) | Solution A (%) | Solution B (%) |
|---|---|---|
| 0 | 22 | 78 |
| 20 | 22 | 78 |
| 33 | 38 | 62 |
| 45 | 38 | 62 |
| 55 | 55 | 45 |
| 65 | 55 | 45 |
| 68 | 22 | 78 |
| 80 | 22 | 78 |
System suitability solution: 1.0 mg/mL of USP Carvedilol System Suitability Mixture RS in Diluent
Sample solution: 1 mg/mL of Carvedilol in Diluent
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 240 nm
Column: 4.6-mm x 15-cm; 5-µm packing L68
Column temperature: 30℃
Flow rate: 1.4 mL/min
Injection size: 20 µL
System suitability
Sample: System suitability solution
Suitability requirements
Resolution: NLT 1.8 between carvedilol and carvedilol related compound F
Analysis
Sample: Sample solution
Calculate the percentage of each impurity in the portion of Carvedilol taken:
Result = (rU/rT) × 100
| rU | = | peak response for each impurity in the Sample solution |
| rT | = | sum of all the peak responses in the Sample solution |
Acceptance criteria: See Table 3.
Table 3
| Name | Relative Retention Time | Acceptance Criteria, NMT (%) | |
|---|---|---|---|
| Carvedilol related compound Aa | 0.7 | 0.1 | |
| Carvedilol | 1.0 | — | |
| Carvedilol related compound Fb | 1.2 | 0.1c | |
| N-Isopropylcarvedilold | 1.6 | 0.1 | |
| Carvedilol related compound Ce | 1.8 | 0.02 | |
| Carvedilol related compound Bf | 2.1 | 0.1 | |
| Biscarbazoleg | 3 | 0.1 | |
| Any other individual impurity | — | 0.1 | |
| Total impurities | — | 0.5 | |
| a 1-(4-(2-Hydroxy-3-(2-(2-methoxyphenoxy)ethylamino)propoxy)-9Hcarbazol-9-yl)-3-(2-(2-methoxyphenoxy)ethylamino) propan-2-ol. b 1-(2-(2-Methoxyphenoxy)ethylamino)-3-(6,7,8,9-tetrahydro-5H-carbazol-4-yloxy)propan-2-ol. c This impurity is quantitated using the procedure under Organic Impurities, Procedure 3: Carvedilol Related Compound F. d 1-(H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]N-isopropylamino]-2-propanol. e 1-(9H-Carbazol-4-yloxy)-3-(benzyl(2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol. f 3,3'-(2-(2-Methoxyphenoxy)ethylazanediyl)bis(1-(9H-carbazol-4-yloxy)propan-2-ol). g 1,3-Bis-(9H-carbazol-4-yloxy)-2-propanol. | |||
• Organic Impurities, Procedure 3: Carvedilol Related Compound F (if present)
Solution A: Trifluoroacetic acid and water (0.5:100)
Solution B: Methanol and trifluoroacetic acid (100:0.5)
Diluent: Water and acetonitrile (1:1)
Mobile phase: Solution A and Solution B (65:35)
System suitability solution: 1.5 mg/mL of USP Carvedilol System Suitability Mixture RS in Diluent
Sample solution: 1.5 mg/mL of Carvedilol in Diluent prepared as follows. Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution.
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 226 nm
Column: 4.6-mm × 30-mm; 3-µm packing L7
Column temperature: 40℃
Flow rate: 2 mL/min
Injection size: 10 µL
System suitability
Sample: System suitability solution
Suitability requirements
Resolution: NLT 2.0 between carvedilol and carvedilol related compound F
Analysis
Sample: Sample solution
Calculate the percentage of carvedilol related compound F in the portion of the sample taken:
Result = (rU/rT) × (1/F) × 100
| rU | = | peak response of carvedilol related compound F from the Sample solution |
| rT | = | sum of the peak responses of carvedilol and carvedilol related compound F from the Sample solution |
| F | = | relative response factor, 1.1 |
Acceptance criteria: NMT 0.1%
SPECIFIC TESTS
• Loss on Drying <731>: Dry a sample at 105℃ for 3 h: it loses NMT 0.5% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.
• Labeling: If a test for Organic Impurities by HPLC other than Procedure 1 is used, then the labeling states the test with which the article complies.
• USP Reference Standards <11>
USP Carvedilol RS
USP Carvedilol Related Compound A RS 1-(4-(2-Hydroxy-3-(2-(2-methoxyphenoxy)ethylamino)propoxy)-9H-carbazol-9-yl)-3-(2-(2-methoxyphenoxy)ethylamino) propan-2-ol. C36H43N3O7 629.74
USP Carvedilol Related Compound B RS 3,3'-(2-(2-Methoxyphenoxy)ethylazanediyl)bis(1-(9H-carbazol-4-yloxy)propan-2-ol). C39H39N3O6 645.74
USP Carvedilol Related Compound C RS 1-(9H-Carbazol-4-yloxy)-3-(benzyl(2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol. C31H32N2O4 496.60
USP Carvedilol Related Compound D RS 4-(Oxiran-2-ylmethoxy)-9H-carbazole. C15H13NO2 239.27
USP Carvedilol Related Compound E RS 2-(2-Methoxyphenoxy)ethyl amine. C9H13NO2 167.21
USP Carvedilol System Suitability Mixture RS Mixture of approximately 0.1% carvedilol related compound F (1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol) in a matrix of carvedilol drug substance.
Related Intermediates:
Related Intermediates of Carvedilol