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Postion:Product Catalog >N-Methyl Zonisamide
N-Methyl Zonisamide
  • N-Methyl Zonisamide
  • N-Methyl Zonisamide
  • N-Methyl Zonisamide
  • N-Methyl Zonisamide
  • N-Methyl Zonisamide

N-Methyl Zonisamide NEW

Price Get Latest Price
Package 10mg 30mg 50mg
Min. Order: 10mg
Supply Ability: 10000000
Update Time: 2025-06-18

Product Details

Product Name: N-Methyl Zonisamide CAS No.: 68292-02-4
Min. Order: 10mg Purity: 95%+
Supply Ability: 10000000 Release date: 2025/06/18

N-Methyl Zonisamide 68292-02-4



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    • Product Information

      • Product Code: Z010003

      • English Name: N-Methyl Zonisamide

      • English Alias: 1-(benzo[d]isoxazol-3-yl)-N-methylmethanesulfonamide

      • CAS Number: 68292-02-4

      • Molecular Formula: C?H??N?O?S

      • Molecular Weight: 226.25

    • Advantages

      • 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.

    • Applications

      • 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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Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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