Betamethasone-17-ketone;3109-01-1
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E-mail: anna@molcoo.com
Product Code：B028045
English Name：Betamethasone-17-ketone
English Alias：(8S,9R,10S,11S,13S,14S,16S)-9-fluoro-11-hydroxy-10,13,16-trimethyl-7,8,9,10,11,12,13,14,15,16-decahydro-3H-cyclopenta[a]phenanthrene-3,17(6H)-dione
CAS No.：3109-01-1
Molecular Formula：C₂₀H₂₅FO₃
Molecular Weight：332.41
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Betamethasone 17-ketone impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-dichloromethane mixture within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of 17-ketone impurity in Betamethasone API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors ketone impurity formation during Betamethasone synthesis, reducing generation by >35% by adjusting oxidation temperature (e.g., 20-30℃) and oxidant dosage (e.g., chromium trioxide concentration).
Method Validation：Serves as a standard for developing steroid impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Betamethasone, a potent glucocorticoid, exhibits anti-inflammatory, anti-allergic, and immunosuppressive effects, commonly used to treat rheumatoid arthritis, allergic diseases, etc. Betamethasone-17-ketone, a potential process impurity in its synthesis, originates from oxidative side reactions of the 17-hydroxy group or intermediate degradation. Its fluorine atom, ketone group, and steroid nucleus may affect drug lipophilicity, receptor binding, and metabolic stability. Strict impurity control for steroid hormones is critical to drug quality, making research on this impurity essential.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 10 minutes, with LOD of 0.005 ng/mL for trace steroid impurity analysis.
Formation Mechanism：Formed by over-oxidation of Betamethasone 17-hydroxy group with oxidizing agents (e.g., Jones reagent) under acidic conditions (e.g., pH 2-3); optimizing reaction pH and time inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 198.3 μM against HCT-116 cells (Betamethasone IC₅₀=1.2 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor ketone reduction risks under high temperature, humidity, and light conditions.
NOTE！
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
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