N-Methyl Zonisamide NEW

$0.00 50mg

$0.00 30mg

$0.00 10mg

Moxin Chemicals

VIP2Y

China

Chemical Properties

N-Methyl Zonisamide 68292-02-4

High-Purity Reference Standard: With ≥99.0% purity (HPLC normalization), its structure is confirmed by 1H/13C NMR and ESI-MS, meeting the requirements of pharmacopoeias such as USP and EP for impurity references.
Strong Stability: Stored at 2-8°C in the dark, it has a shelf life of 24 months, with <1% degradation in solution (e.g., acetonitrile) at room temperature for 7 days, suitable for long-term quality monitoring.
Precise Impurity Tracking: As an N-methylated byproduct of zonisamide, it specifically traces the residual risk of methylation reagents (e.g., methyl iodide) in synthesis, assisting process optimization.

Impurity Quantitative Analysis: Used for HPLC detection of N-Methyl Zonisamide in zonisamide API and formulations, controlling its content ≤0.3% (refer to ICH Q3A standards).
Process Optimization Validation: In methylation reactions, monitoring this impurity's content (e.g., reducing from 0.7% to 0.1% at a 1:1.1 raw material ratio) optimizes methylation reagent dosage to reduce byproduct formation.
Stability Studies: Evaluates the impurity's growth trend in formulations under accelerated stability tests (60°C/RH75%), providing data for packaging material selection (e.g., aluminum foil light-protected packaging).
Regulatory Compliance Support: Helps enterprises meet FDA, EMA, and other requirements for genotoxic impurity (GTI) screening, especially for process routes involving methylation steps.

Background Description：
N-Methyl Zonisamide is an N-methylated impurity introduced by incomplete methylation reactions or reagent excess during zonisamide synthesis. This impurity may affect drug metabolism pathways and increase hepatotoxicity risks. Although ICH M7(R1) does not currently classify it as genotoxic, its methyl sulfonamide structure requires strict control. Pharmacopoeias worldwide mandate its qualitative identification and set specific impurity limits (e.g., individual impurities ≤0.2%).
Research Status：

Detection Technology: HPLC-UV uses a C18 column (4.6×250mm, 5μm) with acetonitrile-0.1% phosphoric acid solution (40:60, v/v) as the mobile phase, detecting at 225nm with a LOQ of 0.05%. LC-MS/MS further lowers the detection limit to 0.01ppm for trace screening.
Formation Mechanism: Mainly originates from excessive reaction of methylation reagents (e.g., methyl iodide, dimethyl sulfate) with intermediates, with significantly increased production at temperatures >50°C or reagent excess >1.5x. Controlled low-temperature (<=30°C) dropwise addition of methylation reagents at a molar ratio of 1:1.05 effectively inhibits impurity formation.
Safety Evaluation: Rat toxicology tests show no obvious toxicity at doses ≤100mg/kg, but long-term exposure may cause mild renal tubular damage, indicating the need for strict limits in drug standards (e.g., ≤0.15%).

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