Azacitidine Impurity

Product Information

• 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：C?H?NO?

• Molecular Weight：175.14

Advantages

• 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.

Applications

• 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).

Background Description

Research Status

• 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 IC?? of 186.4 μM against HL-60 cells (Azacitidine IC??=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.

WhatsAPP: +86 17320513646
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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