Zonisamide Impurity

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

• Product Information

• Product Number: Z010005

• English Name: Zonisamide Impurity 5

• English Alias: 2-(benzo[d]isoxazol-3-yl)acetic acid

• CAS Number: 4865-84-3

• Molecular Formula: C9H7NO3

• Molecular Weight: 177.16

• Advantages: As a reference standard for Zonisamide Impurity 5, it features a well-defined chemical structure with HPLC-verified purity ≥98%, good stability in light-protected and dry environments, and excellent batch-to-batch consistency. Its high purity ensures reliable benchmarking in impurity detection for zonisamide bulk drugs and formulations, supporting validation of analytical methods such as HPLC and NMR, and providing an accurate basis for drug quality control.

• Applications:

• Detection Method Development: Used to establish HPLC methods for detecting Impurity 5 in zonisamide, optimizing mobile phase composition (e.g., methanol-water systems) and detection wavelength (220nm) to achieve quantitative analysis of impurities (detection limit ≤0.05%).

• Process Optimization: Monitors the content of Impurity 5 during zonisamide synthesis (e.g., in carboxylic acid intermediate reactions), adjusting hydrolysis conditions (e.g., temperature, alkali concentration) to reduce its formation and ensure the impurity profile of the bulk drug complies with ICH Q3A requirements.

• Stability Studies: Tracks the content changes of Impurity 5 in long-term stability tests (e.g., 25℃/RH60%) to evaluate the quality stability of drugs during storage and provide data for shelf life determination.

• Regulatory Compliance: Meets the impurity limit requirements (usually ≤0.1%) of regulatory agencies such as FDA and EMA, assisting companies in drug registration and approval.

• Background Description: Zonisamide is a drug used for treating epilepsy, and its synthesis pathway may generate Impurity 5 through carboxylation of the benzisoxazole ring. This impurity is a carboxylic acid compound that may affect the drug's pH balance and stability, potentially triggering degradation reactions over time. Therefore, strict control of this impurity is a key part of the drug's quality system.

• Research Status:

• Detection Technology: Impurity 5 is detected by HPLC-UV using a C18 column (5μm, 4.6×250mm) with methanol-0.1% phosphoric acid solution (50:50, v/v) as the mobile phase at a flow rate of 1.0mL/min, with a limit of quantification (LOQ) of 0.03% (S/N≥10). Some laboratories use LC-MS for structural confirmation to enhance detection accuracy.

• Formation Mechanism: Impurity 5 mainly originates from incomplete hydrolysis of intermediates or side reactions, with its yield correlated to reaction time and pH. Reducing hydrolysis time or adjusting the reaction system to weakly acidic (pH 4-5) can lower impurity content below 0.07%.

• Safety Evaluation: Toxicological data show no significant toxicity of Impurity 5 in rats (LD50＞2000mg/kg), but drug standards still set its limit at ≤0.1% to ensure clinical safety. Currently, companies can control its content below 0.02% through silica gel column chromatography purification.

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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