Fosfomycin Impurity 28;60821-12-7
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：F042028
English Name：Fosfomycin Impurity 28
English Alias：2-ethoxyethyl dihydrogen phosphate
CAS No.：60821-12-7
Molecular Formula：C₄H₁₁O₅P
Molecular Weight：170.10
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C, 31P), HRMS, and elemental analysis, suitable for Fosfomycin impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 28 in Fosfomycin API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during Fosfomycin synthesis, reducing generation by >30% by adjusting ethylation temperature (e.g., 40-50℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Fosfomycin, a broad-spectrum antibiotic, inhibits bacterial cell wall synthesis and is used for treating urinary tract infections, respiratory infections, etc. Impurity 28, a process-related impurity in Fosfomycin synthesis, may originate from phosphorylation or etherification side reactions. Its ethoxy and phosphate groups may affect drug water solubility, stability, and antibacterial activity. Strict impurity control for antibiotics 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 4 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by esterification of phosphoric acid with 2-ethoxyethanol under acidic catalyst (e.g., sulfuric acid); optimizing catalyst dosage and reaction pH inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 205.6 μM against Vero cells (Fosfomycin IC₅₀=12.3 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity 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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