Regulatory Differences Between API and Intermediate Manufacturing: A Practical Guide
Regulatory differences between API and intermediate manufacturing under ICH Q7, FDA, EMA, and NMPA. GMP boundaries, DMF filing, starting material justification.
Canagliflozin Intermediate;2-(4-fluorophenyl)-5-[(5-bromo-2-methylphenyl)methyl]thiophene; 2-(2-methyl-5-bromobenzyl)-5-(4-fluorophenyl)thiophene; 2-[(5-bromo-2-methylphenyl)methyl]-5-(4-fluorophenyl)thiophene
CAS: 1030825-20-7
Chemical Formula: C₁₈H₁₄BrFS
Molecular Weight: 361.27
Availability: R&D; Commercialization
⬤ CAS No.1030825-20-7
⬤ Our Packaging type:
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| Product Name | 2-(5-BroMo-2-Methylbenzyl)-5-(4-fluorophenyl)thiophene |
| CAS.No | 1030825-20-7 |
| Molecular Formula | C₁₈H₁₄BrFS |
| Molecular Weight | 361.27 |
| Related Categories | Canagliflozin intermediates |
| Appearance | Light yellow to white powder |
| Density | 1.388 |
| Melting Point | 103 °C |
| Boiling Point | 438.3±40.0 °C(Predicted) |
| Storage Conditions | Keep in dark place,Sealed in dry,Room Temperature |
| Solubility | Soluble in DMSO (slightly warmed), hexane (slightly warmed) |
| Form | solid |
| Chemical properties | The compound has a thiophene ring structure, as well as brominated and fluorinated substituents, which give it unique reactivity in organic synthesis. |
| Application | Canagliflozin intermediates, a raw material for the treatment of type 2 diabetes in adult patients. |
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June 15, 2024
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April 27, 2024
Regulatory differences between API and intermediate manufacturing under ICH Q7, FDA, EMA, and NMPA. GMP boundaries, DMF filing, starting material justification.
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