Printed on: Wed Feb 08 2023, 11:18:03 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-10A9D44F-0E6A-46AC-ABCD-AAA03D4EBA8C_6_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-Oct-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: rn8m5 DOI: https://doi.org/10.31003/USPNF_M89993_06_01
1

Standard solution: 1 µg/mL of USP Zonisamide RS and 1.5

Zonisamide µg/mL of USP Zonisamide Related Compound A RS in Mobile
phase
Sample solution: 1.0 mg/mL of Zonisamide in Mobile phase
Chromatographic system: Prepare as directed in the Assay.
Run time: 2 times the retention time of the zonisamide peak
System suitability
C8H8N2O3S 212.23 Sample: Standard solution
1,2-Benzisoxazole-3-methanesulfonamide CAS RN®: Suitability requirements
68291-97-4; UNII: 459384H98V. Resolution: NLT 10.0 between zonisamide related
compound A and zonisamide
DEFINITION Relative standard deviation: NMT 10.0% for both
Zonisamide contains NLT 98.0% and NMT 102.0% zonisamide and zonisamide related compound A peaks
of C8H8N2O3S, calculated on the anhydrous basis. Analysis
Samples: Standard solution and Sample solution
IDENTIFICATION Calculate the percentage of zonisamide related compound A
Change to read: in the portion of Zonisamide taken:

• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared
Spectroscopy: 197K▲ (ERR 1-Oct-2020)
• B. The retention time of the major peak of the Sample rU
solution corresponds to that of the Standard solution, as
rS
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
= peak response of zonisamide related compound A
from the Sample solution
= peak response of zonisamide related compound A

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obtained in the Assay.
from the Standard solution
ASSAY CS = concentration of USP Zonisamide Related
• PROCEDURE Compound A RS in the Standard solution
Buffer: 1.36 g/L of monobasic potassium phosphate in (mg/mL)
water. Adjust the pH to 3.0 ± 0.1 with 10% phosphoric acid. CU = concentration of zonisamide in the Sample
Mobile phase: Acetonitrile, methanol, and Buffer (1:1:8)
Standard solution: 0.1 mg/mL of USP Zonisamide RS in
Mobile phase
ci Mr1
solution (mg/mL)
= molecular weight of zonisamide related
compound A (free acid), 213.23
Sample solution: 0.1 mg/mL of Zonisamide in Mobile phase Mr2 = molecular weight of USP Zonisamide Related
Chromatographic system Compound A RS (sodium salt), 235.23
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(See Chromatography á621ñ, System Suitability.)
Mode: LC Calculate the percentage of any unspecified impurity in the
Detector: UV 240 nm portion of Zonisamide taken:
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1.5 mL/min Result = (rU/rS) × (CS/CU) × 100
Injection size: 20 µL
O

System suitability rU = peak response of each impurity from the Sample

Sample: Standard solution solution
Suitability requirements rS = peak response of zonisamide from the Standard
Column efficiency: NLT 5000 theoretical plates solution
Tailing: NMT 1.8 CS = concentration of USP Zonisamide RS in the
Relative standard deviation: NMT 2.0% Standard solution (mg/mL)
Analysis CU = concentration of Zonisamide in the Sample
Samples: Standard solution and Sample solution solution (mg/mL)
Calculate the percentage of C8H8N2O3S in the portion of
Zonisamide taken: Acceptance criteria
Individual impurities: See Impurity Table 1.
Result = (rU/rS) × (CS/CU) × 100 Total impurities: NMT 0.3%

rU = peak response of zonisamide from the Sample Impurity Table 1

solution Relative Acceptance
rS = peak response of zonisamide from the Standard Retention Criteria,
solution Name Time NMT (%)
CS = concentration of USP Zonisamide RS in the Zonisamide related compound Aa 0.51 0.15
Standard solution (mg/mL)
CU = concentration of Zonisamide in the Sample Zonisamide 1.0 —
solution (mg/mL) Any unspecified individual impurity — 0.10

Acceptance criteria: 98.0%–102.0% on the anhydrous a 1,2-Benzisoxazole-3-methane sulfonic acid.

basis
SPECIFIC TESTS
IMPURITIES • WATER DETERMINATION, Method I á921ñ: NMT 0.8%
INORGANIC IMPURITIES
• RESIDUE ON IGNITION á281ñ: NMT 0.1% ADDITIONAL REQUIREMENTS
ORGANIC IMPURITIES • PACKAGING AND STORAGE: Preserve in well-closed
• Procedure containers, and store at room temperature.
Mobile phase: Prepare as directed in the Assay.

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Printed on: Wed Feb 08 2023, 11:18:03 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-10A9D44F-0E6A-46AC-ABCD-AAA03D4EBA8C_6_en-US
Printed by: Dang Van Vu Official Date: Official as of 01-Oct-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: rn8m5 DOI: https://doi.org/10.31003/USPNF_M89993_06_01
2

• USP REFERENCE STANDARDS á11ñ CAS RN®: CAS-73101-64-1.

USP Zonisamide RS
USP Zonisamide Related Compound A RS
1,2-Benzisoxazole-3-methanesulfonic acid sodium salt.
C8H6NNaO4S 235.19

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