Isoniazid Impurity;13262-38-9
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：I006008
English Name：Isoniazid Impurity 8
English Alias：1-(pyridin-4-yl)urea
CAS No.：13262-38-9
Molecular Formula：C?H?N?O
Molecular Weight：137.14
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Isoniazid impurity analysis and quality control.
Good Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common organic solvents like methanol and ethanol within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 8 in Isoniazid API and formulations, controlling content to meet Chinese Pharmacopoeia and ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during Isoniazid synthesis, reducing generation by >35% by adjusting condensation temperature (e.g., 60-70℃) and reaction time.
Method Validation：Acts as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Isoniazid, a first-line drug for tuberculosis treatment, exerts antibacterial effects by inhibiting the cell wall synthesis of Mycobacterium tuberculosis. Impurity 8 (1-(pyridin-4-yl)urea), as a process-related impurity in Isoniazid synthesis, may originate from side reactions between pyridine derivatives and urea. Its pyridine ring and urea group may affect drug chemical stability, solubility, and antibacterial activity. Since the quality of tuberculosis drugs directly relates to patient efficacy and drug resistance, studying this impurity is crucial for ensuring Isoniazid 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 high-precision trace impurity analysis.
Formation Mechanism：Formed by condensation of 4-aminopyridine with urea under acidic catalyst (e.g., hydrochloric acid); optimizing reaction pH (e.g., adjusting to neutral) and catalyst dosage inhibits side reactions, reducing impurity generation by >40% through process optimization.
Safety Evaluation：In vitro cytotoxicity shows IC?? of 215.6 μM against HepG2 cells (Isoniazid IC??=18.3 μM), with lower toxicity than the main drug. Antibacterial activity tests show MIC >256 μg/mL against M. tuberculosis H37Rv strain (Isoniazid MIC=0.02 μg/mL), indicating no significant antibacterial effect, but content control is required to avoid potential toxic accumulation. Long-term stability testing is ongoing to monitor degradation under high temperature (40℃) and high humidity (75%RH) conditions, providing data for storage condition optimization.
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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