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.
Ethyl 3-pyridinecarboxylate; Ethyl pyridine-3-carboxylate; Nicotinic acid ethyl ester; 3-Pyridinecarboxylic acid ethyl ester; 2,4-dimethoxy-N-[(E)-2-(1,3,3-trimethyl-2-indol-1-iumyl)ethenyl]aniline
CAS:614-18-6
Chemical Formula:C8H9NO2
Molecular Weight:151.16
Availability: R&D; Commercialization
⬤ CAS No.614-18-6
⬤ Packaging type:
20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| Product Name | Ethyl nicotinate |
| CAS No. | 614-18-6 |
| Chemical Formula | C8H9NO2 |
| Molecular Weight | 151.16 |
| Related Categories | Pharmaceutical intermediates; Chemical products-Organic chemicals; Organic raw materials |
| Melting point | 8-10 °C (lit.) |
| Boiling point | 223-224 °C (lit.) |
| Density | 1.107 g/mL at 25 °C (lit.) |
| Vapor pressure | 4.2-5.5Pa at 20-25℃ |
| Refractive index | n20/D 1.504(lit.) |
| Flash point | 93 °C |
| Storage conditions | Store below +30°C. |
| Solubility | 50 g/L |
| Acidity coefficient (pKa) | pK1:3.35(+1) (25°C) |
| Specific gravity | 1.107 |
| Color | Light yellow |
| Water solubility | miscible |
| BRN | 122937 |
| InChlkey | XBLVHTDFJBKJLG-UHFFFAOYSA-N |
| LogP | 1.32 |
| Surface tension | 72mN/m at 1g/L and 20℃ |
| Safety Information | Ethyl nicotinate is a carboxylic acid ester derivative and is widely used in the synthesis of medicines as an important basic chemical raw material. |
| Application | For organic synthesis |
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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.
Finerenone drug class: third‑generation non‑steroidal MRA. Compare selectivity, potency, half‑life, and safety vs spironolactone/eplerenone. FDA‑approved for CKD+T2D and HF with LVEF ≥40%.
Finerenone mechanism of action: a non‑steroidal mineralocorticoid receptor antagonist with high MR selectivity, balanced cardiorenal distribution, no active metabolites, and lower hyperkalemia risk vs steroidal MRAs.
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