Local adoption & batch approval

Reference documentation. The actual use requires review, local adoption and batch approval.

MASTER FORMULA / v8.0

The source formula

Reference basis: 1000 g

Ingredient	Source quantity	Scaled quantity
Zinc oxide JP	500g	—
Olive Oil JP	q.s. ad 1000g	—

q.s.: sufficient quantity · ad: to a final total. Ingredient identities and source quantities are retained exactly from v8. ^[1]

FORMULA SCALING / 9.0

Calculate proportional quantities.

Arithmetic scaling of the same formula. It does not change strength, dose, method or BUD.

Prerequisite formulations

No separate prerequisite monograph is listed. Appropriate raw-material quality is still required.

Full documentation

Preparation descriptionDocumented in source

White to whitish viscous suspension; partial separation can occur on standing. ^[1]

SpecificationsDocumented in source

Nominal ZnO 50% w/w. Pharmacopoeial ZnO assay range 45.0–55.0% w/w. Zinc identification according to JP. ^[1]

Compounding methodEditorial procedure for local review

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]

Quality controlPartial evidence

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]}

Action and usePartial evidence

Cutaneous protective ZnO preparation. The monograph establishes composition/quality, without a dosing regimen. It is not for ophthalmic use or applications requiring sterility. ^{[1], [3]}

LightPartial evidence

Limit light exposure of oil and mixture; use a light-resistant container. Light protection is an additional practical measure for the selected oil. ^{[1], [2]}

Air and oxidationPartial evidence

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 solubilityPartial evidence

ZnO is practically insoluble in water and remains dispersed in oil. The selected formula adds no water. Aqueous dilution or liquid additions change the formulation and require a new preservation/BUD assessment. ^{[1], [3]}

HumidityEditorial checklist

Use completely dry equipment and containers; exclude wash water and condensation. No numerical finished-product relative-humidity limit is specified. ^[1]

TemperaturePartial evidence

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 compatibilityDocumented in source

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 interactionsPartial evidence

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 informationDocumented in source

Selected oil: Olive Oil JP from Olea europaea, not liquid paraffin. Raw-material acid value ≤1.0 and saponification value 186–194. The ZnO lot must be identified and released. Oil limits are not whole-suspension specifications. ^{[2], [3]}

Compounding conditionsEditorial checklist

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 protectionPartial evidence

Wear laboratory clothing, protective gloves and goggles during trituration/transfer. Contain airborne ZnO using suitable local powder control. Perform ignition/acid QC reactions in an appropriate analytical area with extraction. ^{[1], [3]}

Risk assessmentEditorial checklist

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]}

EquipmentEditorial checklist

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 packagingPartial evidence

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]

StoragePartial evidence

Tight, light-resistant container at 20–25 °C for the selected general BUD category. Exclude water and prolonged air exposure. ^{[1], [2]}

DispensingEditorial specimen

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]

ObservationsPartial evidence

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. ^{[1], [2]}

PrerequisitesDocumented in source

No separately registered base is required. ^[1]

BUD rationaleGeneral framework, subject to conditions

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. ^{[1], [4], [6]}

LabellingEditorial specimen

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]

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

SIKALIAS GREEK FORMULARY / CALCULATION SHEET

Zinc Oxide Oil JP 50% w/w — Olive Oil JP variant

CGR-JP-015 · Reference edition 8.0 · Web 9.0

THEORETICAL CALCULATION SHEET — Not an approved master record or batch release. BUD and process parameters are not calculated by this tool.

Calculated at:

Laboratory / local record: __________Batch / date: __________

Ingredient	Source	Calculated	Lot	Actual amount

Prepared by: __________Independent check: __________Equipment / minimum weight: __________Locally approved BUD / rationale: __________

Use with the complete monograph. Complete lot and actual-quantity columns in the laboratory. The ≈ symbol denotes arithmetic rounding, not balance accuracy.

https://compounding.gr/monographs/cgr-jp-015/