Isoniazid Impurity;13262-38-9

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

Product Information

• 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

Advantages

• 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.

Applications

• 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).

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 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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