Zonisamide USP Related Compound C NEW

Product Code: Z010002

English Name: Zonisamide USP Related Compound C

English Alias: N'-((benzo[d]isoxazol-3-ylmethyl)sulfonyl)-N,N-dimethylformimidamide

CAS Number: 1217201-89-2

Molecular Formula: C₁₁H₁₃N₃O₃S

Molecular Weight: 267.30

High-Purity Standard: With ≥99.0% purity (HPLC normalization), its structure is confirmed by 1H/13C NMR, MS, and elemental analysis, meeting USP standards for direct methodology validation.

Excellent Stability: Stored at 2-8°C in the dark, it has a shelf life of 24 months, with <0.5% degradation in solution (e.g., acetonitrile-water) within 72 hours, suitable for long-term testing needs.

Multi-Platform Compatibility: Compatible with HPLC, LC-MS, and other detection technologies, serving as a system suitability reference to evaluate chromatographic resolution.

USP Specified Impurity Detection: Used for quantitative analysis of Related Compound C in zonisamide API, controlled at ≤0.2% according to USP methods.

Synthesis Process Monitoring: As a byproduct of sulfonamidation reactions, its content in intermediates is monitored in real time. Adjusting dimethylamine dosage or reaction time reduces impurity levels from 0.6% to below 0.1%.

Forced Degradation Testing: As a degradation product standard in acid/alkali stress tests, it validates the method's ability to capture degradation impurities, ensuring comprehensive impurity profile analysis.

Generic Drug Development Support: Provides reference impurities for generic manufacturers to facilitate in vitro dissolution and impurity profile consistency studies.

Detection Technology: HPLC-UV uses a C18 column (4.6×250mm, 5μm) with methanol-0.05M potassium dihydrogen phosphate (55:45, v/v, pH 3.5) as the mobile phase, detecting at 225nm with a LOQ of 0.03% (S/N≥10). LC-MS/MS enables trace detection (LOQ 0.01ppm) for genotoxic impurity screening.

Formation Mechanism: Originating from the nucleophilic substitution side reaction between sulfonyl chloride intermediates and dimethylamine, its yield increases significantly at temperatures >40°C or with dimethylamine excess >2x. Controlled low-temperature dropwise addition of dimethylamine (molar ratio 1:1.2) effectively inhibits its formation.

Safety Evaluation: In vitro Ames tests show no mutagenicity, but a 90-day rat repeated-dose study revealed mild hepatic enzyme elevation at the 0.5% dose, indicating the need for strict residual control in formulations.