Zonisamide USP Related Compound A(Sodium salt) NEW

Product Code: Z010001A

English Name: Zonisamide USP Related Compound A(Sodium salt)

English Alias: sodium benzo[d]isoxazol-3-ylmethanesulfonate

CAS Number: 73101-64-1

Molecular Formula: C₈H₆NNaO₄S

Molecular Weight: 234.20

USP-Compliant: As a USP-specified reference standard for Zonisamide Related Compound A sodium salt, it has a purity of ≥99.0% (HPLC) and is directly applicable for USP methodology validation.

High Stability: The sodium salt form enhances water solubility and chemical stability, with a degradation rate of <1% at room temperature in pH 4-8 buffers within 24 hours, suitable for impurity studies in solution formulations.

Precise Traceability: Provides complete structural confirmation data (e.g., ¹H/¹³C NMR, IR, elemental analysis) to ensure consistency with USP reference standards.

USP Methodology Validation: Used for developing HPLC methods to detect Related Compound A in zonisamide API, serving as a system suitability reference to validate column resolution (required resolution from the main peak >2.0).

Impurity Quantification Standard: Acts as an external standard in assay to calibrate impurity peak areas, ensuring Related Compound A content is controlled at ≤0.5% (USP standard).

Formulation Compatibility Studies: Evaluates the stability of the sodium salt in tablet coatings or injectables, analyzing interactions with excipients (e.g., magnesium stearate, polyethylene glycol).

Genotoxicity Assessment: As a potential precursor of nitroso impurities, it is used to assess the risk of genotoxic impurity formation during formulation storage.

Detection Methods: The USP-recommended method uses HPLC-UV with a C18 column (4.6×150mm, 3.5μm) and methanol-0.1% phosphoric acid solution (40:60, v/v) as the mobile phase, detecting at 225nm with a LOQ of 0.1% (S/N≥10).

Process Control: Optimizing salification reaction conditions (e.g., sodium hydroxide concentration, reaction temperature) can reduce Related Compound A content from 1.2% to below 0.3%. Novel membrane separation technologies (e.g., nanofiltration) further remove sodium salt impurities to enhance API purity.

Safety Data: Acute toxicity tests show the sodium salt has an LD₅₀ >2000mg/kg in mice, classified as low toxicity, but it must still adhere to USP's control requirements for specified impurities to ensure clinical safety.