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    Zonisamide Compounded Oral Suspension

    Uploaded by

    Kasidit Sornchai
    This document provides instructions for preparing a zonisamide compounded oral suspension containing between 90-110% of the labeled amount of zonisamide. It defines the suspension as containing crushed zonisamide capsules equivalent to 1g mixed with a 1:1 vehicle of Ora-Plus and Ora-Sweet to make a total of 100mL. The assay procedure uses LC with UV detection to analyze samples of the standard solution and oral suspension and calculate the percentage of zonisamide. The suspension must have a pH between 3.9-4.9 and is stable for 90 days if stored properly between 2-8°C.

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    Zonisamide Compounded Oral Suspension

    Uploaded by

    Kasidit Sornchai
    41 views1 page
    This document provides instructions for preparing a zonisamide compounded oral suspension containing between 90-110% of the labeled amount of zonisamide. It defines the suspension as containing crushed zonisamide capsules equivalent to 1g mixed with a 1:1 vehicle of Ora-Plus and Ora-Sweet to make a total of 100mL. The assay procedure uses LC with UV detection to analyze samples of the standard solution and oral suspension and calculate the percentage of zonisamide. The suspension must have a pH between 3.9-4.9 and is stable for 90 days if stored properly between 2-8°C.

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    This document provides instructions for preparing a zonisamide compounded oral suspension containing between 90-110% of the labeled amount of zonisamide. It defines the suspension as containing crushed zonisamide capsules equivalent to 1g mixed with a 1:1 vehicle of Ora-Plus and Ora-Sweet to make a total of 100mL. The assay procedure uses LC with UV detection to analyze samples of the standard solution and oral suspension and calculate the percentage of zonisamide. The suspension must have a pH between 3.9-4.9 and is stable for 90 days if stored properly between 2-8°C.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    41 views1 page

    Zonisamide Compounded Oral Suspension

    Uploaded by

    Kasidit Sornchai
    This document provides instructions for preparing a zonisamide compounded oral suspension containing between 90-110% of the labeled amount of zonisamide. It defines the suspension as containing crushed zonisamide capsules equivalent to 1g mixed with a 1:1 vehicle of Ora-Plus and Ora-Sweet to make a total of 100mL. The assay procedure uses LC with UV detection to analyze samples of the standard solution and oral suspension and calculate the percentage of zonisamide. The suspension must have a pH between 3.9-4.9 and is stable for 90 days if stored properly between 2-8°C.

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    © All Rights Reserved
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    Printed on: Tue Aug 03 2021, 07:49:58 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-82D57D7D-D3D5-4FE1-977E-D332518CDC8F_1_en-US

    (EST)
    Printed by: Le Tran Official Date: Official as of 01-Aug-2015 Document Type: USP @2021 USPC
    1

    Chromatographic system
    Zonisamide Compounded Oral (See Chromatography á621ñ, System Suitability.)
    Suspension Mode: LC
    Detector: UV 264 nm
    DEFINITION Column: 4.6-mm × 15-cm; 3.5-µm packing L1
    Zonisamide Compounded Oral Suspension contains NLT Column temperature: 32°
    90.0% and NMT 110.0% of the labeled amount of Flow rate: 1.0 mL/min
    zonisamide (C8H8N2O3S). Injection volume: 50 µL
    Prepare Zonisamide Compounded Oral Suspension 10 mg/mL System suitability
    as follows (see Pharmaceutical Compounding—Nonsterile Sample: Standard solution
    Preparations á795ñ). [NOTE—The retention time for zonisamide is about
    4.6 min.]
    Zonisamide capsulesa equivalent to 1g Suitability requirements
    Tailing factor: NMT 2.0
    Vehicle: a 1:1 mixture of Ora-Plusb and Relative standard deviation: NMT 2.0% for replicate
    Ora-Sweet (regular or sugar-free),b
    a sufficient quantity to make 100 mL
    injections
    Analysis
    a Zonisamide 100-mg capsules, Mylan, Morgantown, WV. Samples: Standard solution and Sample solution
    b Paddock Laboratories, Minneapolis, MN. Calculate the percentage of the labeled amount of
    zonisamide (C8H8N2O3S) in the portion of Oral Suspension
    Empty the capsules, and pour the contents into a mortar or taken:
    other suitable container. Crush the capsule contents into a

    al
    fine powder using a pestle or other mechanical means. Wet Result = (rU/rS) × (CS/CU) × 100
    the powder with a small amount of Vehicle, and triturate to
    make a smooth paste. Add the Vehicle to make the mortar rU = peak response of zonisamide from the Sample
    contents pourable. Transfer the contents, stepwise and solution
    quantitatively, to a calibrated container using the remainder rS = peak response of zonisamide from the Standard
    of the Vehicle. Add sufficient Vehicle to bring to final volume, solution
    and mix well. [CAUTION—Avoid skin contact or inhalation of
    zonisamide by using protective gloves and a fume hood or
    surgical mask.]
    ci CS

    CU
    = concentration of zonisamide in the Standard
    solution (mg/mL)
    = nominal concentration of zonisamide in the
    Sample solution (mg/mL)
    ASSAY
    ffi
    • PROCEDURE Acceptance criteria: 90.0%–110.0%
    Solution A: 50 mM sodium phosphate adjusted with
    phosphoric acid to a pH of 2.8 SPECIFIC TESTS
    Mobile phase: Acetonitrile and Solution A (25:75) • PH á791ñ: 3.9–4.9
    Standard stock solution: 1 mg/mL of USP Zonisamide RS ADDITIONAL REQUIREMENTS
    in Mobile phase. Sonicate for 10 min. • PACKAGING AND STORAGE: Package in tight, light-resistant
    O

    Standard solution: Transfer 1 mL of the Standard stock containers. Store at 2°–8° or at controlled room
    solution to a 10-mL volumetric flask, dilute with temperature.
    Mobile phase to volume, and mix well. Centrifuge an aliquot • BEYOND-USE DATE: NMT 90 days after the date on which it
    of the solution for 10 min at 13,000 rpm. was compounded when stored at 2°–8° or at controlled
    Sample solution: Shake each bottle of Oral Suspension room temperature.
    thoroughly. Transfer 1 mL of Oral Suspension to a 10-mL • LABELING: Label it to indicate that it is to be well shaken
    volumetric flask, dilute with Mobile phase to volume, and before use, and to state the Beyond-Use Date.
    mix well. Vortex for 30 s, and sonicate for 10 min. Transfer • USP REFERENCE STANDARDS á11ñ
    1 mL of the resultant solution to a 10-mL volumetric flask, USP Zonisamide RS
    and dilute with Mobile phase to volume. Centrifuge an
    aliquot of the solution for 10 min at 13,000 rpm.

    https://online.uspnf.com/uspnf/document/1_GUID-82D57D7D-D3D5-4FE1-977E-D332518CDC8F_1_en-US 1/1

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