Dabigatran Etexilate iMpurity, also known as Dabigatran 3-?Amino-?3-?oxopropyl, is an impurity found in Dabigatran (D100090), a nonpeptide direct thrombin inhibitor and antithrombotic agent. It is a compound that may be present during the synthesis or manufacturing process of Dabigatran and is important to monitor and control for quality assurance and safety purposes.
1643377-48-3
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Basic information
- Product Name: Dabigatran Etexilate iMpurity
- Synonyms: Dabigatran Etexilate iMpurity;Dabigatran Etexilate IMP;Dabigatran impurity;N-(3-amino-3-oxopropyl)-2-(((4-carbamimidoylphenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamide
- CAS NO:1643377-48-3
- Molecular Formula: C25H26N8O2
- Molecular Weight: 470.53
- EINECS: N/A
- Product Categories: N/A
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Chemical Properties
- Melting Point: N/A
- Boiling Point: 826.0±75.0 °C(Predicted)
- Flash Point: N/A
- Appearance: /
- Density: 1.38±0.1 g/cm3(Predicted)
- Refractive Index: N/A
- Storage Temp.: N/A
- Solubility: N/A
- PKA: 16.03±0.40(Predicted)
- CAS DataBase Reference: Dabigatran Etexilate iMpurity(CAS DataBase Reference)
- NIST Chemistry Reference: Dabigatran Etexilate iMpurity(1643377-48-3)
- EPA Substance Registry System: Dabigatran Etexilate iMpurity(1643377-48-3)
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Safety Data
- Hazard Codes: N/A
- Statements: N/A
- Safety Statements: N/A
- WGK Germany:
- RTECS:
- HazardClass: N/A
- PackingGroup: N/A
- Hazardous Substances Data: 1643377-48-3(Hazardous Substances Data)
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1643377-48-3 Usage
Uses
Used in Pharmaceutical Industry:Dabigatran Etexilate iMpurity is used as a quality control parameter for the production of Dabigatran, a direct thrombin inhibitor and antithrombotic agent. The presence and concentration of this impurity are monitored to ensure the safety, efficacy, and purity of the final drug product.
Used in Research and Development:
Dabigatran Etexilate iMpurity is used as a reference compound in the development of analytical methods and techniques for the detection, quantification, and control of impurities in Dabigatran. This helps in the optimization of manufacturing processes and the development of new, more efficient methods for impurity control.
Used in Regulatory Compliance:
Dabigatran Etexilate iMpurity is used in the context of regulatory compliance to meet the requirements set by various health authorities and agencies. By monitoring and controlling the levels of this impurity, pharmaceutical companies can demonstrate compliance with guidelines and ensure the quality of their products.
Used in Drug Safety Assessment:
Dabigatran Etexilate iMpurity is used in the assessment of drug safety, as understanding the potential effects of impurities on the safety profile of a drug is crucial. This information can help in the evaluation of potential risks and the establishment of acceptable limits for impurities in the final drug product.
Check Digit Verification of cas no
The CAS Registry Mumber 1643377-48-3 includes 10 digits separated into 3 groups by hyphens. The first part of the number,starting from the left, has 7 digits, 1,6,4,3,3,7 and 7 respectively; the second part has 2 digits, 4 and 8 respectively.Calculate Digit Verification of CAS Registry Number 1643377-48:
(9*1)+(8*6)+(7*4)+(6*3)+(5*3)+(4*7)+(3*7)+(2*4)+(1*8)=183
183 % 10 = 3
So 1643377-48-3 is a valid CAS Registry Number.
1643377-48-3Upstream product
1643377-48-3Downstream Products
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Dabigatran Etexilate iMpurity
