Zinc Oxide Ointment JP 20% w/w

White ointment.

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Cutaneous ointment containing protective zinc oxide. JP specifies quality and composition; this monograph does not prescribe a clinical dose.

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White ointment containing 18.5–21.5% w/w ZnO. JP identification, purity and assay tests apply. No specific pH, numerical viscosity or beyond-use period is given.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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ZnO: practically insoluble in water and ethanol.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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ZnO dissolves in dilute mineral acids and forms soaps with fatty acids.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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Exact identities: Οξείδιο ψευδαργύρου / Zinc oxide; Υγρή παραφίνη / Liquid paraffin; Λευκή αλοιφή JP (CGR-JP-005) / White Ointment JP (CGR-JP-005). Use pharmacopoeial raw materials of the referenced edition, with CoA verification. Do not arbitrarily change salt, hydration state or strength. Record the actual q.s. amount in the batch.

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JP provides no specific numerical room limits for this formula. Define a local SOP covering suitable clean conditions, temperature control and contamination prevention. This is an editorial checklist.

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Clean protective clothing and head covering under AEMPS PN/L/PG/002/00. Use suitable gloves where contact is possible and respiratory/eye protection where powder handling requires it. Exact glove material, ventilation and respiratory protection must follow the SDS and local exposure assessment.

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A 20% solid dispersion requires homogeneity. Limit exposure to ZnO dust. The analytical method involves ignition, acids and ammonia and requires a separate risk assessment.

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The specific monograph provides no finished-product beyond-use period/BUD. No duration is assigned by assumption. Suitable stability evidence and responsible-pharmacist approval are required before release.

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CGR-JP-005 — Λευκή αλοιφή JP / White Ointment JP
Referenced bases are included in the package; also check their dependencies.

• CGR-JP-005 · White Ointment JP

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Balance with suitable resolution, mortar/spatula, suitable mixing vessels and final container. Add volumetric equipment for mL, a controlled water bath where melting is specified and a suitable filter where required. Analytical equipment follows the QC methods.

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1. Prepare and check White Ointment JP (CGR-JP-005).
2. Weigh ZnO 200 g, liquid paraffin 30 g and base to 1000 g (theoretically 770 g base).
3. Disperse ZnO in the lipophilic components and knead until homogeneous under JP 11-4. Levigation of ZnO with paraffin before gradual base incorporation is a proposed local implementation requiring approval, not a specifically validated monograph step.

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JP permits other bases using individual constituents without quantitative detail here. This record exclusively selects the explicit White Ointment JP formula.

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Tight container.

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Zinc Oxide Ointment JP 20% w/w
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Keep tightly closed. No specific temperature or beyond-use period is prescribed.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.

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Identification: ignite a 1 g sample; residue is yellow while hot and white on cooling. Its acid solution gives a white precipitate with potassium hexacyanoferrate(II). Purity: perform the full JP calcium, magnesium and other inorganic-impurity test (2 g sample, acid dissolution of ash, oxalate/phosphate reactions after ammonia). Assay: ignite an accurately weighed sample of about 2 g, dissolve in acid and dilute to 100 mL. Titrate a 20 mL aliquot with 0.05 mol/L EDTA at buffer pH 10.7 using eriochrome black T. Each mL equals 4.069 mg ZnO in the aliquot; dilution factor 5 applies to the full sample. Limit: 18.5–21.5% w/w. Full JP instructions and a suitable analytical laboratory are required.

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Keep tightly closed. No specific temperature or beyond-use period is prescribed.

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Cutaneous use following pharmacist/clinician assessment. The source provides no frequency, treatment duration or specific paediatric directions. Sterility is not claimed.

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