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.
Cortodoxon 21-acetate;17-Hydroxy-3,20-dioxopregn-4-en-21-yl acetate;
21-(Acetyloxy)-17-hydroxypregn-4-ene-3,20-dione;
11-Deoxycortisol 21-acetate
CAS: 640-87-9
Chemical Formula: C23H32O5
Molecular Weight: 388.5
Availability: R&D; Commercialization
⬤ CAS No.640-87-9
⬤ Our Packaging type:
20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| Product Name | Cortexolone 21-Acetate |
| CAS No. | 640-87-9 |
| Chemical Formula | C23H32O5 |
| Molecular Weight | 388.5 |
| Related Categories | Clascoterone Intermediate Cortodoxone Intermediates |
| Melting Point | 233–235 °C |
| Boiling Point | 537.9 °C (at 760 mmHg; predicted) |
| Density | 1.4 g/cm³ |
| Flash Point | 181.8 °C |
| Refractive Index | 1.558 |
| LogP | 3.38 |
| pKa | 12.59 ± 0.60 (predicted) |
| Appearance/Form | Crystalline solid (typical steroid form) |
| Color | White to off-white |
| Solubility | Sparingly soluble in chloroform; slightly soluble in methanol (when heated) |
| Storage | Refrigerated (2–8 °C) |
| Mechanism of Action | Cortexolone 21‑acetate (CAS 640‑87‑9) acts as a synthetic steroid intermediate and partial agonist of progesterone and glucocorticoid receptors, regulating gene transcription to exert anti‑inflammatory and mineralocorticoid‑modulating effects while serving as a key precursor for cortisone and hydrocortisone production. |
| Application | Cortexolone 21‑acetate (CAS 640‑87‑9) is mainly used as a key pharmaceutical intermediate for synthesizing hydrocortisone, cortisone and other corticosteroid drugs. |
Reliable Global Partner
“Tianming Pharmaceutical has redefined reliability for us. Their ability to deliver high-potency APIs and intermediates under tight deadlines—is unmatched. The team’s transparency in documentation and proactive updates make them a stress-free partner. A true backbone for our operations!”
March 18, 2024
Outstanding Technical Guidance
“Few suppliers align so perfectly with EU GMP requirements. Tianming’s commitment to audit-ready quality systems, batch traceability, and purity consistency has streamlined our production processes. Their diligence eliminates regulatory risks—a rare advantage in today’s market.”
February 15, 2024
Beyond Supplier, A Solutions Partner
“Tianming’s technical team doesn’t just deliver materials—they solve problems. When we faced stability challenges with a niche compound, their scientists proposed a tailored purity adjustment that saved our project timeline. Their agility transforms obstacles into opportunities.”
June 15, 2024
Strategic Growth Ally
“Over 5+ years, Tianming has consistently adapted to our evolving needs—whether scaling volumes or supporting custom synthesis projects. Their ethical pricing models and long-term vision make them more than a vendor; they’re integral to our competitive edge.”
April 27, 2024
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.
Leading provider of high-quality APIs and intermediates. Contact us for innovative solutions and expert support.