REFERENCE FORMULA
Reference formula
Reference basis: 100 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| White beeswax | 13 g | — |
| Liquid paraffin | 53.5 g | — |
| Borax | 0.5 g | — |
| Rose water Ph. Fr. | 33 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-FR-004 · Modified Galen cerate Ph. Fr.
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
- Αρωματικό ύδωρ ρόδου Ph. Fr. ή επιτρεπόμενο κεκαθαρμένο ύδωρ / Rose water Ph. Fr. or expressly permitted purified water
Documentation
Preparation description
Homogeneous white to nearly white ointment, rose odour or odourless, not miscible with water. [1]
Action and use
Topical emollient and skin protectant according to the monograph. [1]
Specifications
Loss on drying 28–38%. [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
Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water. [4]
Humidity
Borax is efflorescent; verify the exact hydrated raw-material form. [2]
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
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
Borax: incompatibilities with strong acids and heavy-metal salts. [2]
Ingredient-specific information
Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP. [4]
Staff protection
Risk assessment
Reference batch: 100 g. First ingredient: White beeswax, 13 g. Independently check chemical form, units and every scale conversion before weighing.
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
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.
Retain the monograph’s exclusion below 3 years. Additionally calculate total daily boron from the exact borax hydrate and actual maximum application amount. Current EMA wording uses 1, 3 and 7 mg B/day for age-dependent warnings/medical assessment (<2, <12 and <18 years), with a pregnancy warning at the upper level. These values are not dosing instructions, aw thresholds or proof of safety on damaged skin. [1], [9], [11], [13]
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
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.
Retain the monograph’s exclusion below 3 years. Additionally calculate total daily boron from the exact borax hydrate and actual maximum application amount. Current EMA wording uses 1, 3 and 7 mg B/day for age-dependent warnings/medical assessment (<2, <12 and <18 years), with a pregnancy warning at the upper level. These values are not dosing instructions, aw thresholds or proof of safety on damaged skin. [1], [9], [11], [13]
Compounding conditions
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
Selected conservative general rule: up to 14 days at 2–8 °C for an aqueous form without adequately established preservation. Refrigeration must not cause precipitation, irreversible separation or other loss of suitability. If that condition fails, do not apply 14 days at room temperature; obtain specific short-use evidence.
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 clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately. [1], [8], [10], [12]
Selected conservative general rule: up to 14 days at 2–8 °C for an aqueous form without adequately established preservation. Refrigeration must not cause precipitation, irreversible separation or other loss of suitability. If that condition fails, do not apply 14 days at room temperature; obtain specific short-use evidence.
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 clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately. [1], [8], [10], [12]
Prerequisites
Rose water Ph. Fr. or expressly permitted purified water — source-permitted variant must be recorded; no unqualified fragrance substitution [1]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
Compounding method
Melt wax in paraffin near 50 °C, never above 60 °C. Dissolve borax in rose water and emulsify gradually. [1]
Observations
Purified water may replace rose water. Excludes children below 3 years. [1]
Container and packaging
Tube or jar. [1]
Quality control
Homogeneity: about 0.2 g between two glass slides, no visible particles. Loss on drying at 105°C for 4 h: 28–38%. Perform boron identification only using the full source method and safety controls.
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], [11]
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], [11]
Storage
Dispensing
Contraindicated below 3 years according to the monograph.
Emollient residues on clothing, dressings or bedding accelerate fabric ignition. Avoid smoking and naked flames during use.
Before paediatric or pregnancy use, record amount per application/day and resulting boron exposure; the historical “above 3 years” wording alone does not complete suitability assessment. [1], [6], [13]
Emollient residues on clothing, dressings or bedding accelerate fabric ignition. Avoid smoking and naked flames during use.
Before paediatric or pregnancy use, record amount per application/day and resulting boron exposure; the historical “above 3 years” wording alone does not complete suitability assessment. [1], [6], [13]
Labelling
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
- Cérat de Galien modifié (2010) (15/02/2012)2010PDF pp. 1–2master formula2026-10-14
- FN/2003/PA/006 BÓRAXΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- 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
- 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> FAQsUpdated 1 November 2023Questions 52, 54–56, 60–62; PDF pp. 11–14Primary clarification of aw classification, extension prerequisites and compounded-component BUDs; not automatic Greek legal adoption2026-10-14
- EMA — Excipients in the labelling and package leaflet, Annex Revision 5Published 5 December 2025EN and EL worksheets: boric acid and borates (updated 29 March 2022)Boron exposure/age-specific scientific warnings; dose assessment, not permission to use this formula2026-10-14