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.
L-Alanine,N-[(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-, 1-methylethyl ester, (2E)-2-butenedioate (2:1)
CAS:1392275-56-7
Chemical Formula:C25H33N6O9P
Molecular Weight:592.55
Availability: R&D; Commercialization
⬤ CAS No.1392275-56-7
⬤ Packaging type:20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| Product Name | Tenofovir alafenamide hemifumarate |
| CAS No. | 1392275-56-7 |
| Chemical Formula | C25H33N6O9P |
| Molecular Weight | 592.55 |
| EINECS | 805-448-8 |
| Related Categories | API; Pharmaceuticals; Antiviral drugs |
| Storage conditions | Keep in dark place,Sealed in dry,Room Temperature |
| Solubility | DMSO: 75.0 (maximum concentration mg/mL); 70.16 (maximum concentration mM) |
| Form | Solid |
| Color | White to off-white |
| Side Effects | The use of tenofovir alafenamide hemifumarate may cause adverse reactions such as headache, vomiting, diarrhea, fatigue, stomach discomfort, increased liver enzymes, and increased blood sugar. |
| Kidney problems | The drug has been shown to cause kidney problems, including acute kidney failure, kidney stones, and renal tubular damage, so patients who take it long-term should have their kidney function checked regularly. |
| Application | Tenofovir alafenamide fumarate can be used as a solvent, catalyst for alkylation, esterification and polymerization reactions. Most of the product is mainly used in medicine. |
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June 15, 2023
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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