REFERENCE FORMULA
Reference formula
Reference basis: 1000 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Zinc oxide JP | 500 g | — |
| Olive Oil JP | q.s. ad 1000 g | — |
REFERENCE FORMULA SCALING
Proportional quantities of the same formula
Arithmetic aid. It does not change strength, dose, method or BUD and does not authorise compounding.
Theoretical calculation sheet
CGR-JP-015 · Zinc Oxide Oil JP 50% w/w — Olive Oil JP variant
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
White to whitish viscous suspension; partial separation can occur on standing. [1]
Specifications
Nominal ZnO 50% w/w. Pharmacopoeial ZnO assay range 45.0–55.0% w/w. Zinc identification according to JP. [1]
Compounding method
1. Verify ZnO and Olive Oil JP grades; weigh 500 g ZnO.
2. JP requires mixing with fixed oil. For this selected variant, levigate with a small portion of olive oil to a uniform paste without dry aggregates.
3. Progressively incorporate the remaining oil to 1000 g total, without adding water.
4. Check uniformity, redispersibility and final mass. Fill containers while maintaining uniform suspension. Levigation sequence is a practical expansion of the general mixing instruction. [1]
2. JP requires mixing with fixed oil. For this selected variant, levigate with a small portion of olive oil to a uniform paste without dry aggregates.
3. Progressively incorporate the remaining oil to 1000 g total, without adding water.
4. Check uniformity, redispersibility and final mass. Fill containers while maintaining uniform suspension. Levigation sequence is a practical expansion of the general mixing instruction. [1]
Quality control
Identify ZnO by ignition and the specified zinc reactions. Assay by ignition, acid dissolution and 0.05 mol/L EDTA titration under JP conditions and blank; 1 mL corresponds to 4.069 mg ZnO. pH 10.7 belongs to the analytical buffer, not the oily product. In-process checks cover aggregates, redispersibility and representative samples from the start/end of filling.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [7]
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [7]
Action and use
Light
Air and oxidation
Olive oil must be non-rancid. Minimise open handling, close promptly after filling and check changes in odour/colour. No specific inert-atmosphere requirement is established. [2]
Water and solubility
Humidity
Use completely dry equipment and containers; exclude wash water and condensation. No numerical finished-product relative-humidity limit is specified. [1]
Temperature
Olive Oil JP can partially congeal at 0–6 °C. Select 20–25 °C storage and do not use refrigeration by default. The practical method requires no heating; freeze–thaw compatibility is not established. [2]
pH and compatibility
Do not assign an arbitrary pH to the nonaqueous oil. The pH 10.7 buffer in the ZnO assay applies only to the analytical solution. Do not add buffers or acids to the product. [1]
Other interactions
ZnO reacts with acids and strong bases; do not combine with additional actives without assessment. This selected variant does not establish compatibility with another oil or container material. [3]
Ingredient-specific information
Compounding conditions
Dry, clean workspace with powder containment during weighing/trituration. Maintain uniform mixing until filling is complete. Record oil identity, masses and actual yield. [1]
Staff protection
Risk assessment
Key nonuniformity risk: high ZnO loading and sedimentation can change strength between containers. Redisperse before subdivision and check representative start/end filling samples. Water ingress, rancid oil or a hard non-redispersible cake preclude release.
Reference batch: 1000 g. First ingredient: Zinc oxide JP, 500 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity. [1], [2], [5], [7]
Reference batch: 1000 g. First ingredient: Zinc oxide JP, 500 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity. [1], [2], [5], [7]
Equipment
Balance with suitable range/minimum weight, dry mortar/pestle or appropriate homogeniser, spatulas and dry filling containers. Pharmacopoeial assay requires furnace/crucible, volumetric equipment, EDTA titration apparatus and JP reagents. [1]
Container and packaging
JP requires a tight container. Select a compatible light-resistant container with room for redispersion and a closure preventing water ingress. The monograph does not specify a particular polymer. [1]
Storage
Dispensing
External use only. Shake/redisperse thoroughly before each application; do not use if uniformity cannot be restored. Avoid eyes and mucosa. Dose/frequency follow the prescription. [1]
Observations
JP allows a fixed oil; Olive Oil JP is selected here to define the formula. Other oils, water addition or wetting agents constitute another variant requiring separate evidence.
The reviewed source remains English JP XVIII. PMDA confirms JP XIX publication on 10 April 2026 and schedules English publication within one year. This work did not complete a comparison of the full final Japanese text of all relevant monographs; no JP XIX conformity is claimed. [1], [2], [9]
The reviewed source remains English JP XVIII. PMDA confirms JP XIX publication on 10 April 2026 and schedules English publication within one year. This work did not complete a comparison of the full final Japanese text of all relevant monographs; no JP XIX conformity is claimed. [1], [2], [9]
Prerequisites
No separately registered base is required. [1]
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
Selected general rule: up to 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. [1], [4], [6], [8]
Selected general rule: up to 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. [1], [4], [6], [8]
Labelling
Zinc Oxide Oil JP 50% w/w — Olive Oil JP variant
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tight, light-resistant container at 20–25 °C for the selected general BUD category. Exclude water and prolonged air exposure.
Shake/redisperse well before use.
Temperature for this batch BUD: ____ [1]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tight, light-resistant container at 20–25 °C for the selected general BUD category. Exclude water and prolonged air exposure.
Shake/redisperse well before use.
Temperature for this batch BUD: ____ [1]
v9_controls
The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- MHLW — Japanese Pharmacopoeia XVIII: Zinc Oxide OilJP XVIII, 2021, English textPrinted p. 1929; PDF p. 646Master formula, description, identification, assay and container2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Olive OilJP XVIII, 2021, English textPrinted pp. 2081–2082; PDF pp. 143–144Identity and quality of the selected fixed oil; congealing at 0–6 °C; acid value ≤1.02026-09-12
- FN/2003/PA/028 ÓXIDO DE ZINCRetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQs (official, updated 1 November 2023)Updated 1 November 2023; retrieved 14 October 2026Q52, Q61–64; use with the applicable full chapterWater-activity classification, component dating and BUD documentation; general professional framework, not a Greek legal adoption or formula-specific study2026-10-14
- PMDA — JP publication schedule / Frequently Asked QuestionsCurrent official schedule, retrieved 14 October 2026JP19 published 10 April 2026; English edition scheduled within one yearEdition status only; not a comparison of individual JP19 monographs2026-10-14