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.
5-Bromo-4-fluoro-1-methylindazole; 1H-Indazole, 5-bromo-4-fluoro-1-methyl-; 5-Bromo-4-fluoro-1-m; Orforglipron Intermediates
CAS: 1784678-61-0
Chemical Formula: C₈H₆BrFN₂
Molecular Weight: 229.05
Availability: R&D; Commercialization
⬤ CAS No.1784678-61-0
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| Product Name | 5-bromo-4-fluoro-1-methyl-1H-indazole |
| CAS.No | 1784678-61-0 |
| Molecular Formula | C₈H₆BrFN₂ |
| Molecular Weight | 229.05 |
| Related Categories | Orforglipron Intermediates |
| Appearance | solid |
| Boiling Point | 293.4±20.0 °C(Predicted) |
| Density | 1.70±0.1 g/cm³ (Predicted) |
| Acidity coefficient(pKa) | -0.38±0.30 (Predicted) |
| Flash Point | 131.3±21.8 °C (Predicted) |
| Chemical Structure | The compound is a halogenated indazole derivative, and its structural characteristics are that the benzene ring is fused with the pyrazole ring, the bromine and fluorine atoms are connected at the 5-position and 4-position respectively, and the methyl group is connected at the 1-position. |
| Dangerous goods signs | GHS07 Warning |
| Hazard Labeling | H302 (Note: Harmful if swallowed) |
| Application | 5-Bromo-4-fluoro-1-methyl-1H-indazole is an important intermediate in the synthesis of potential drug candidates in various therapeutic areas, including cancer, neurodegenerative diseases, and infectious diseases. |
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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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