Printed on: Thu Feb 09 2023, 12:35:03 AM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-775FDC02-A195-4BF6-A351-422BA04AE483_2_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-Mar-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: 9lq3z DOI: https://doi.org/10.31003/USPNF_M24990_02_01
1

Calculate the percentage of the labeled amount of

Dicloxacillin Sodium Capsules dicloxacillin (C19H17Cl2N3O5S) in the portion of Capsules
DEFINITION taken:
Dicloxacillin Sodium Capsules contain NLT 90.0% and NMT
120.0% of the labeled amount of dicloxacillin Result = (rU/rS) × (CS/CU) × P × F × 100
(C19H17Cl2N3O5S).
rU = peak area from the Sample solution
IDENTIFICATION rS = peak area from the Standard solution
• A. The retention time of the dicloxacillin peak of the CS = concentration of USP Dicloxacillin Sodium RS in
Sample solution corresponds to that of the Standard the Standard solution (mg/mL)
solution, as obtained in the Assay. CU = nominal concentration of dicloxacillin in the
Sample solution (mg/mL)
ASSAY P = potency of dicloxacillin in USP Dicloxacillin
• PROCEDURE Sodium RS (µg/mg)
Buffer: 2.72 g/L of monobasic potassium phosphate in F = conversion factor, 0.001 mg/µg
water, adjusted with 8 N potassium hydroxide to a pH of
5.0 ± 0.1 Acceptance criteria: 90.0%–120.0%
Mobile phase: Acetonitrile and Buffer (50:150)
Standard solution: 1.1 mg/mL of USP Dicloxacillin PERFORMANCE TESTS
Sodium RS in Buffer. Use the Standard solution promptly, or
refrigerate and use on the day prepared. Change to read:
Sample solution: Nominally 1 mg/mL of dicloxacillin in • DISSOLUTION á711ñ
Buffer, prepared as follows. Remove, as completely as

al
Medium: Water; 900 mL
possible, the contents of NLT 10 Capsules. Transfer a Apparatus 1: 100 rpm
suitable portion of the powder to a volumetric flask, dilute Time: 30 min
with Buffer to volume, and mix for 10 min with the aid of a Standard solution: USP Dicloxacillin Sodium RS in Medium
magnetic stirrer. Pass a portion of the solution through a Sample solution: Sample per the chapter. ▲Pass a portion
suitable filter, discarding the first 5 mL of the filtrate. Use of the solution under test through a suitable
the clear filtrate. Use the Sample solution promptly, or
refrigerate and use on the day prepared.
Chromatographic system
ci ▲
filter.▲ (ERR 1-Mar-2020) Dilute with Medium to a concentration
that is similar to the Standard solution.
Instrumental conditions
(See Chromatography á621ñ, System Suitability.) Mode: UV-Vis▲ (ERR 1-Mar-2020)
Mode: LC
Tolerances: NLT 75% (Q) of the labeled amount of
ffi
Detector: UV 225 nm
dicloxacillin (C19H17Cl2N3O5S) is dissolved.
Column: 4.6-mm × 25-cm; packing L1
Flow rate: 2 mL/min • UNIFORMITY OF DOSAGE UNITS á905ñ: Meet the
Injection volume: 10 µL requirements
System suitability SPECIFIC TESTS
Sample: Standard solution • WATER DETERMINATION á921ñ, Method I: NMT 5.0%
O

Suitability requirements
Column efficiency: NLT 700 theoretical plates ADDITIONAL REQUIREMENTS
Tailing factor: NMT 2.0 • PACKAGING AND STORAGE: Preserve in tight containers.
Capacity factor: 4–11 • USP REFERENCE STANDARDS á11ñ
Relative standard deviation: NMT 2.0% USP Dicloxacillin Sodium RS
Analysis
Samples: Standard solution and Sample solution

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