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.
CAS:2212020-52-3
Chemical Formula:C48H48F2N10O5
Molecular Weight:882.97
Availability: R&D; Commercialization
⬤ CAS No.2212020-52-3
⬤ Packaging type:20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| Product Name | Orforglipron |
| CAS No. | 2212020-52-3 |
| Chemical Formula | C48H48F2N10O5 |
| Molecular Weight | 882.97 |
| Related Categories | Anti-sugar API |
| Storage Conditions | Store at -20°C |
| density | 1.50±0.1 g/cm3(Predicted) |
| Solubility | Dimethyl sulfoxide: 125 mg/mL (141.57 mM) |
| Form | solid |
| Acidity coefficient (pKa) | 7.33±0.20(Predicted) |
| Color | Off-white to light yellow |
Note | Orforglipron is a novel oral GLP-1 receptor agonist (GLP-1 RA) currently in clinical trials (data as of 2023). Its safety information is mainly based on publicly available clinical research data and known risks of similar drugs, mainly manifested as gastrointestinal reactions. |
| Application | The core applications of Orforglipron API focus on type 2 diabetes and obesity. |
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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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