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
Acrinol hydrate JP, very finely powdered	10g	—
Zinc Oxide Oil JP — CGR-JP-015	990g	—

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

CGR-JP-015 · Zinc Oxide Oil JP 50% w/w — Olive Oil JP variant

Full documentation

Preparation descriptionDocumented in source

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

SpecificationsDocumented in source

Nominal acrinol hydrate 1% w/w. A 50% ZnO base gives nominal ZnO 49.5% w/w; official ZnO assay range is 44.6–54.4% w/w. This monograph provides no separate numerical acrinol assay range. ^[1]

Compounding methodEditorial procedure for local review

1. Prepare and release CGR-JP-015 using Olive Oil JP. Fully redisperse before taking 990 g. 2. Weigh 10 g very finely powdered Acrinol Hydrate JP and levigate with a small portion of the homogeneous base. 3. Progressively incorporate the remaining base to a uniform 1000 g total. 4. Check colour uniformity, aggregates, redispersibility and mass; package with light protection. The selected variant adds no water or other wetting agents. ^[1]

Quality controlPartial evidence

Identify acrinol by acidic nitrite reaction and TLC at 365 nm against the reference standard. Identify ZnO in the ignited residue. Use the JP EDTA ZnO assay and this product’s 44.6–54.4% range. Follow complete reagents/extractions in JP pp. 415–416. In-process checks include uniform colour and redispersibility. 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. JP requires light protection for the acrinol product. ^{[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 informationPartial evidence

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. Acrinol Hydrate JP: exact hydrated form, 10 g per 1000 g. The base contains 50% ZnO before incorporation and is sampled only after full redispersion. ^{[1], [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: Acrinol hydrate JP, very finely powdered, 10 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 with light protection. 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

Requires released, fully redispersible CGR-JP-015 using Olive Oil JP. ^[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

Acrinol Hydrate 1% and Zinc Oxide Oil JP 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: Acrinol and Zinc Oxide OilJP XVIII, 2021, English textPrinted pp. 415–416; PDF pp. 17–18Master 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

Acrinol Hydrate 1% and Zinc Oxide Oil JP

CGR-JP-016 · 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-016/