REFERENCE FORMULA
Reference formula
Reference basis: 1000 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Zinc oxide | 200 g | — |
| Liquid paraffin | 30 g | — |
| White Ointment JP (CGR-JP-005) | 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-006 · Zinc Oxide Ointment JP 20% w/w
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
Documentation
Preparation description
White ointment. [1]
Action and use
Specifications
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. [1]
Light
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidation
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubility
ZnO: practically insoluble in water and ethanol.
Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water.
Component of base CGR-JP-005: White Petrolatum: JP classifies the corresponding pure raw material as practically insoluble in water. [4], [5], [9], [10]
Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water.
Component of base CGR-JP-005: White Petrolatum: JP classifies the corresponding pure raw material as practically insoluble in water. [4], [5], [9], [10]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [1]
pH and compatibility
ZnO dissolves in dilute mineral acids and forms soaps with fatty acids. [4]
Other interactions
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
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.
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP.
Component of base CGR-JP-005: White Petrolatum: raw-material water solubility is classified as practically insoluble by JP. [1], [4], [5], [9], [10]
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP.
Component of base CGR-JP-005: White Petrolatum: raw-material water solubility is classified as practically insoluble by JP. [1], [4], [5], [9], [10]
Compounding conditions
Staff protection
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.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [3], [6]
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [3], [6]
Risk assessment
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.
Reference batch: 1000 g. First ingredient: Zinc oxide, 200 g. Independently check chemical form, units and every scale conversion before weighing.
Check uniform active distribution and absence of aggregates after cooling. Overheating, water ingress or a changed base alter the preparation; record actual yield and transfer losses.
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: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. [1], [12], [14]
Reference batch: 1000 g. First ingredient: Zinc oxide, 200 g. Independently check chemical form, units and every scale conversion before weighing.
Check uniform active distribution and absence of aggregates after cooling. Overheating, water ingress or a changed base alter the preparation; record actual yield and transfer losses.
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: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. [1], [12], [14]
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], [11], [13], [15]
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], [11], [13], [15]
Prerequisites
White Ointment JP: CGR-JP-005 [1]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities.
Calibrated pH meter and suitable check buffers. [1]
Calibrated pH meter and suitable check buffers. [1]
Compounding method
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. [1], [2]
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. [1], [2]
Observations
JP permits other bases using individual constituents without quantitative detail here. This record exclusively selects the explicit White Ointment JP formula.
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], [16]
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], [16]
Container and packaging
Tight container. [1]
Labelling
Zinc Oxide Ointment JP 20% w/w
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Keep tightly closed. No specific temperature or beyond-use period is prescribed.
Temperature for this batch BUD: ____ [1]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Keep tightly closed. No specific temperature or beyond-use period is prescribed.
Temperature for this batch BUD: ____ [1]
Quality control
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.
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], [2], [14]
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], [2], [14]
Storage
Dispensing
Cutaneous use following pharmacist/clinician assessment. The source provides no frequency, treatment duration or specific paediatric directions. Sterility is not claimed.
Emollient residues on clothing, dressings or bedding accelerate fabric ignition. Avoid smoking and naked flames during use. [1], [7]
Emollient residues on clothing, dressings or bedding accelerate fabric ignition. Avoid smoking and naked flames during use. [1], [7]
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 — JP XVIII: Zinc Oxide Ointment JP 20% w/w2021JP XVIII (2021), printed pp. 1929–1930; General Rules 11-4, p. 20specific formulation2026-09-10
- MHLW — JP XVIII, General Rules for Preparations202111-4 Ointments and 11-2 Cutaneous liquids, printed p. 20; Other Preparations 3 Spirits, p. 22; General Noticesgeneral procedure2026-09-10
- PN/L/PG/002/00 INDUMENTARIAPN/L/PG/002/00Clothing and protective equipmentgeneral procedure2026-09-10
- FN/2003/PA/028 ÓXIDO DE ZINCFN/2003/PA/028Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Liquid ParaffinJP XVIII, 2021; English textPrinted p. 1477; Description; Containers and storageraw-material monograph2026-09-12
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- MHRA — Emollients and risk of severe and fatal burns: new resources available26 August 2020; updated 20 May 2021Fabric contamination and fire riskclinical safety2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: White PetrolatumJP XVIII, 2021; English textPrinted p. 1501; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — JP XVIII: White Ointment JP2021JP XVIII (2021), printed p. 1921; General Rules for Preparations 11-4, p. 20specific formulation2026-09-10
- 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