Azacitidine Impurity
Product Code：A040037
English Name：Azacitidine Impurity 37
English Alias：(3aS,5R,6R,6aR)-6-hydroxy-5-(hydroxymethyl)tetrahydrofuro[2,3-d]oxazol-2(5H)-one
CAS No.：2508-81-8
Molecular Formula：C₆H₉NO₅
Molecular Weight：175.14
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Azacitidine impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in acetonitrile-water solution within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 37 in Azacitidine API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors Impurity 37 formation during Azacitidine synthesis, reducing generation by >50% by adjusting cyclization temperature (e.g., 50-60℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥2.5) and LOD (0.01 ng/mL).
Azacitidine, a DNA methyltransferase inhibitor, is used for treating myelodysplastic syndromes and other hematological disorders. Impurity 37, as a process-related impurity of Azacitidine, may originate from condensation side reactions of furan and oxazole rings or raw material residues during synthesis. Its hydroxyl and hydroxymethyl groups may affect drug stability and efficacy. With stricter FDA and EMA requirements for anticancer drug impurities, studying Impurity 37 is crucial for ensuring drug quality.
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 0.003 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by reaction of hydroxyacetaldehyde with amino acid derivatives under acidic conditions (e.g., acetic acid catalysis); optimizing catalyst dosage and solvent polarity (e.g., ethanol-water system) inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 186.4 μM against HL-60 cells (Azacitidine IC₅₀=12.7 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.
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E-mail: anna@molcoo.com
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 17320513646
E-mail: anna@molcoo.com
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