Printed on: Tue Aug 03 2021, 07:41:04 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-70B4A837-8757-4D20-8E9F-D07B7D2411EB_4_en-US

(EST)
Printed by: Le Tran Official Date: Official as of 01-May-2020 Document Type: USP @2021 USPC
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Sample solution: Nominally 20 µg/mL of zinc oxide in

Zinc Oxide Powder water from the Sample stock solution
DEFINITION System suitability
Zinc Oxide Powder contains NLT 90.0% and NMT 110.0% of Sample: Standard solution
the labeled amount of zinc oxide (ZnO). Suitability requirements
Tailing factor: NMT 2.0
IDENTIFICATION Relative standard deviation: NMT 2.0%
• A. The retention time of the zinc peak of the Sample Analysis
solution corresponds to that of the Standard solution, as Samples: Standard solution and Sample solution
obtained in the Assay. Calculate the percentage of the labeled amount of zinc
oxide (ZnO) in the portion of Powder taken:
ASSAY
Change to read: Result = (r U/r S) × (C S/C U) × 100

• PROCEDURE rU = peak response of zinc from the Sample solution

Proceed as directed in ▲Zinc Determination á591ñ, Ion rS = peak response of zinc from the Standard solution
Chromatographic Method▲ (CN 1-May-2020). CS = concentration of USP Zinc Oxide RS in the
Diluent: 0.2% (w/v) hydrochloric acid Standard solution (µg/mL)
Standard solution: 20 µg/mL of USP Zinc Oxide RS in CU = nominal concentration of zinc oxide in the Sample
Diluent, prepared as directed in the chapter solution (µg/mL)
Sample stock solution: Nominally 500 µg/mL of zinc oxide
prepared as follows. Transfer an appropriate amount of Acceptance criteria: 90.0%–110.0%

al
Powder to a suitable volumetric flask. Add hydrochloric acid
ADDITIONAL REQUIREMENTS
to about 15% of the final volume of the flask.
• PACKAGING AND STORAGE: Preserve in tight containers, and
[NOTE—Sonication or shaking may be necessary.] Dilute
store at room temperature.
with water to volume. Centrifuge or pass a portion of this
solution through a suitable filter. ci
ffi
O

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