2/28/25, 2:32 PM USP-NF Zinc Oxide Compounded Paste
Printed on: Fri Feb 28 2025, 14:31:47 pm
Printed by: PROTOGENE HAKIZIMANA
Status: Currently Official on 28-Feb-2025
Official Date: Official as of 01-May-2019
Document Type: USP Monographs
DocId: GUID-46DA600B-7D26-4394-A999-E1176EBF773F_2_en-US
DOI: https://doi.org/10.31003/USPNF_M89710_02_01
DOI Ref: t0ltr
Printed from: https://online.uspnf.com/uspnf/document/1_GUID-46DA600B-7D26-4394-A999-E1176EBF773F_2_en-US
© 2025 USPC
Do not distribute
Change to read:
Zinc Oxide ▲Compounded▲ (USP 1-May-2019) Paste
DEFINITION
Change to read:
Zinc Oxide ▲Compounded▲ (USP 1-May-2019) Paste contains NLT 24.0% and NMT 26.0% of zinc oxide (ZnO). Prepare Zinc Oxide
▲Compounded
▲ (USP 1-May-2019) Paste as follows.
Zinc Oxide 250 g
Starch 250 g
White Petrolatum 500 g
L
To make 1000 g
Mix the ingredients.
IA
IDENTIFICATION
• A. The residue obtained in the Assay is yellow when hot and white when cool.
ASSAY
IC
Change to read:
• Procedure
Sample solution: Transfer 600 mg of Paste to a porcelain crucible. Heat gently until melted, and continue heating, gradually raising the
temperature until the mass is thoroughly charred. Ignite the mass until the residue is uniformly yellow, and cool. Dissolve the residue in 10
mL of 2 N sulfuric acid, warming if necessary to dissolve.
FF
Titrimetric system
▲(See Titrimetry 〈541〉.)
▲ (USP 1-May-2019)
Mode: Direct titration
Titrant: 0.05 M edetate disodium VS
O
Endpoint detection: Visual
Analysis: Transfer the Sample solution to a beaker, and rinse the crucible with small portions of water until the combined solution and rinsings
measure 50 mL. Add 15 mL of ammonia–ammonium chloride buffer TS and 1 mL of eriochrome black TS, and titrate with Titrant until the
solution is blue in color. Each milliliter of Titrant is equivalent to 4.069 mg of zinc oxide (ZnO).
Acceptance criteria: 24.0%–26.0%
PERFORMANCE TESTS
• Minimum Fill 〈755〉: Meets the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage: Package in well-closed containers, and avoid prolonged exposure to temperatures exceeding 30°.
Auxiliary Information - Please check for your question in the FAQs before contacting USP.
https://online.uspnf.com/uspnf/document/1_GUID-46DA600B-7D26-4394-A999-E1176EBF773F_2_en-US?source=Search Results&highlight=Zinc Oxi… 1/2
2/28/25, 2:32 PM USP-NF Zinc Oxide Compounded Paste
Topic/Question Contact Expert Committee
Brian Serumaga
ZINC OXIDE COMPOUNDED PASTE CMP2020 Compounding 2020
Science Program Manager
RS Technical Services
REFERENCE STANDARD SUPPORT CMP2020 Compounding 2020
[email protected]
Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:
Pharmacopeial Forum: Volume No. PF 43(6)
Current DocID: GUID-46DA600B-7D26-4394-A999-E1176EBF773F_2_en-US
DOI: https://doi.org/10.31003/USPNF_M89710_02_01
DOI ref: t0ltr
L
IA
IC
FF
O
https://online.uspnf.com/uspnf/document/1_GUID-46DA600B-7D26-4394-A999-E1176EBF773F_2_en-US?source=Search Results&highlight=Zinc Oxi… 2/2
