Product Introduction - Betamethasone Intermediate
Basic Information
Name: 9β,11β-Epoxy-16β-methyl-17α-hydroxy-21-acetoxypregna-1,4-diene-3,20-dione
Other names: Betamethasone Intermediate; 9β,11β-epoxide 21-acetate
Molecular formula: C₂₄H₃₀O₆
Molecular weight: 414.50
CAS number: -
2.Physical and Chemical Properties
- Appearance: white or off-white crystalline powder
- Melting point: approximately 195–205 °C
- Specific optical rotation: [α]D20 ≈ +95° to +105° (c 1.0, dioxane)
- Solubility: slightly soluble in water; readily soluble in acetone, ethyl acetate, dichloromethane; soluble in methanol, ethanol
- Stability: stable at ambient temperature; store sealed, protected from light, at low temperature
3.Main Functions and Applications (What are its uses?)
- Key intermediate for betamethasone (core application): the 9,11-epoxide ring is opened by HF in a single step to introduce the 9α-fluoro and 11β-hydroxy groups, forming the heart of the betamethasone skeleton.
- Precursor for glucocorticoid APIs and their esters: betamethasone (CAS 378-44-7), betamethasone 21-acetate (CAS 987-24-6), betamethasone sodium phosphate and related ester derivatives.
- Chiral intermediate: the fixed 16β-methyl and epoxide handle provide high diastereoselectivity in downstream transformations.
4.A Benchmark-Level Industrial Masterpiece-A Meticulously Crafted "API-Grade" Cornerstone Intermediate!
Assay reaches ≥99.0%, with total related substances ≤1.0% and the largest single impurity ≤0.5%.
Ultra-low moisture (≤0.5%) and residue on ignition (≤0.1%) protect the sensitive 9,11-epoxide from hydrolysis and minimize inorganic contamination.
Heavy metals ≤20 ppm meets pharmaceutical-grade expectations.
Consistent specific optical rotation (+95° to +105°) and crystal habit guarantee reproducible diastereoselectivity and optical purity.
The fixed 9,11-epoxide handle enables one-step regio- and stereoselective HF opening to 9α-fluoro-11β-hydroxy. "What you see is what you get"-every lot ships with a complete certificate of analysis.
Chromatographic Analysis - Betamethasone Intermediate B06
Signal: VWD1 A, Wavelength=240 nm (C18 column, 4.6 mm × 250 mm × 5 μm; acetonitrile–water gradient; flow rate 1.0 mL/min)
|
Retention Time (min) |
Type |
Peak Width (min) |
Peak Area |
Peak Height |
Area% |
|
4.180 |
BB |
0.102 |
2.8 |
0.5 |
0.018 |
|
6.860 |
BB |
0.134 |
9.8 |
1.6 |
0.064 |
|
8.520 |
BB |
0.142 |
6.4 |
1.1 |
0.042 |
|
10.240 |
BV |
0.168 |
15214.6 |
1850.4 |
99.520 |
|
12.580 |
VB |
0.156 |
23.9 |
3.4 |
0.156 |
|
14.120 |
BB |
0.172 |
13.5 |
1.9 |
0.088 |
|
16.340 |
BB |
0.184 |
8.0 |
1.2 |
0.052 |
|
18.020 |
BB |
0.196 |
5.2 |
0.8 |
0.034 |
|
19.480 |
BB |
0.208 |
4.0 |
0.6 |
0.026 |
- Determination method: Karl Fischer titration (standard: ≤ 0.5%) Moisture content 0.18%
- Determination method: Loss on drying (standard: ≤ 0.5%)
- Loss on drying 0.12%
- Test method: Residue on ignition (specification limit: ≤ 0.1%) Residue on ignition 0.02%
- Test method: Capillary melting point method (reference range: 195–205 °C) Melting point 200.3 °C
- Determination method: Polarimetry (c 1.0, 1,4-dioxane; reference range: +95° to +105°) Specific optical rotation +98.6°
Product Specification
|
Product model |
Betamethasone Intermediate B06 (9,11-epoxide 21-acetate) |
|
Appearance |
White or off-white crystalline powder |
|
Assay (HPLC, %) |
≥ 99.0 |
|
Related substances (total, %) |
≤ 1.0 |
|
Largest single impurity (%) |
≤ 0.5 |
|
Melting point (°C) |
195 – 205 * |
|
Specific optical rotation [α]D²⁰ |
+95° – +105° (c 1.0, dioxane) * |
|
Water content (%, Karl Fischer) |
≤ 0.5 |
|
Loss on drying (%) |
≤ 0.5 |
|
Residue on ignition (%) |
≤ 0.1 |
|
Heavy metals (ppm) |
≤ 20 |
|
Packaging |
25 kg fiber drum, double PE inner bag |
Test methods reference: HPLC related-substances/assay (ChP general chapter 0512), Karl Fischer water determination (ChP 0832 / GB-T 6283), loss on drying (ChP 0831), residue on ignition (ChP 0841), heavy metals (ChP 0821).
* Reference values; the exact melting point and specific optical rotation should be confirmed against the supplier's batch certificate
of analysis.
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