Final editorial decision
Final development reference — not an executable patient-compounding protocol.
The official ANSM text limits heating to 30 °C while requiring wool fat and white soft paraffin to be melted at 30 °C. This source inconsistency is recorded. An arbitrary higher temperature or unverified cold process is not adopted. The composition is presented solely for documentation and development.
No numerical BUD is assigned to this development entry. The source supplies no specific duration. An aw result or general dating rule does not resolve the unsupported process. Any future production version requires an approved method, container, storage conditions and dating justification.
Required evidence
- ANSM clarification/correction or separately identified local development protocol addressing melting at 30 °C.
- Specifications and CoAs for wool fat, petrolatum and calcium hydroxide solution matching Ph. Fr.
- Protocol and actual results for structure/uniformity, calcium identification, microbial quality and container compatibility at the stated storage conditions.
Closure criteria
- The exact process is reproducible for actual materials without unsupported heating above 30 °C; any modified method is declared separately.
- Actual tests meet prospectively approved specifications; the selected duration and temperature are supported and approved for the batch.
Scope
Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.
Sources and references
- ANSM, Formulaire national 2007, Crème oléocalcaireSingle page, PREPARATION
- USP General Chapter <795> FAQs, updated 1 November 2023Q52, Q54–56, Q58–65, PDF pp.11–15
REFERENCE FORMULA
Reference formula
Reference basis: 100 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Calcium hydroxide solution Ph. Fr. | 25 g | — |
| Refined almond oil | 25 g | — |
| Wool fat | 25 g | — |
| White soft paraffin | 25 g | — |
Prerequisite formulations
- Διάλυμα υδροξειδίου ασβεστίου Ph. Fr. / Calcium hydroxide solution Ph. Fr.
Documentation
Preparation description
Pale-yellow cream with characteristic wool-fat odour. [1]
Action and use
Topical emollient and skin protectant according to the monograph. [1]
Specifications
Composition and final quantity follow the formula table (100 g). The reviewed specific text gives no numerical assay, microbial-count or physicochemical acceptance range; no unsupported limit is assigned. [1]
Light
Protect almond oil from light. [2]
Air and oxidation
Almond oil: protect from air to limit rancidity. [2]
Water and solubility
White Petrolatum: JP classifies the corresponding pure raw material as practically insoluble in water. [5]
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
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
Calcium hydroxide: carbonates, phosphates, citrates and sulfates may cause precipitation. [3]
Ingredient-specific information
White Petrolatum: raw-material water solubility is classified as practically insoluble by JP. [5]
Staff protection
Risk assessment
Reference batch: 100 g. First ingredient: Calcium hydroxide solution Ph. Fr., 25 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.
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.
Contains lanolin, which can cause local skin reactions including contact dermatitis. [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.
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.
Contains lanolin, which can cause local skin reactions including contact dermatitis. [1], [9], [11], [13]
Compounding conditions
BUD rationale
No numerical BUD is assigned to this development entry. The source supplies no specific duration. An aw result or general dating rule does not resolve the unsupported process. Any future production version requires an approved method, container, storage conditions and dating justification. [1], [12]
Prerequisites
Calcium hydroxide solution Ph. Fr. — qualified source-standard intermediate; BP solution not presumed equivalent [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
The official ANSM text limits heating to 30 °C while requiring wool fat and white soft paraffin to be melted at 30 °C. This source inconsistency is recorded. An arbitrary higher temperature or unverified cold process is not adopted. The composition is presented solely for documentation and development. [1], [12]
Observations
The formula contains 25% petrolatum and 25% wool fat. The instruction to melt at 30 °C does not establish complete melting of this fatty phase. A confirmed thermal protocol or experimentally validated cold incorporation with structure/uniformity checks is required. Do not arbitrarily select a higher temperature.
Retain the ANSM limit ≤30 °C. A confirmed process for the actual wool fat and petrolatum must document rheological state, incorporation and uniformity. Cold processing may be investigated as local development; it is not pharmacopoeial validation.
Re-reading the official ANSM text confirms both the 30 °C maximum and the melting instruction at 30 °C. Do not silently amend it to 60 or 70 °C as an alleged typo without publisher clarification or local development. Actual-material specification review and a trial demonstrating structure/uniformity remain prerequisites. [1], [11]
Retain the ANSM limit ≤30 °C. A confirmed process for the actual wool fat and petrolatum must document rheological state, incorporation and uniformity. Cold processing may be investigated as local development; it is not pharmacopoeial validation.
Re-reading the official ANSM text confirms both the 30 °C maximum and the melting instruction at 30 °C. Do not silently amend it to 60 or 70 °C as an alleged typo without publisher clarification or local development. Actual-material specification review and a trial demonstrating structure/uniformity remain prerequisites. [1], [11]
Container and packaging
Tube or jar. [1]
Quality control
Disperse 5.0 g in 50 mL water, acidify with acetic acid and cool; the aqueous phase gives the calcium reaction in Ph. Eur. 2.3.1.
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
final_decision
Final development reference — not an executable patient-compounding protocol.
The official ANSM text limits heating to 30 °C while requiring wool fat and white soft paraffin to be melted at 30 °C. This source inconsistency is recorded. An arbitrary higher temperature or unverified cold process is not adopted. The composition is presented solely for documentation and development.
No numerical BUD is assigned to this development entry. The source supplies no specific duration. An aw result or general dating rule does not resolve the unsupported process. Any future production version requires an approved method, container, storage conditions and dating justification. [1], [12]
The official ANSM text limits heating to 30 °C while requiring wool fat and white soft paraffin to be melted at 30 °C. This source inconsistency is recorded. An arbitrary higher temperature or unverified cold process is not adopted. The composition is presented solely for documentation and development.
No numerical BUD is assigned to this development entry. The source supplies no specific duration. An aw result or general dating rule does not resolve the unsupported process. Any future production version requires an approved method, container, storage conditions and dating justification. [1], [12]
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- Crème oléocalcaire (2007) (15/02/2012)2007PDF pp. 1–1master formula2026-10-14
- FN/2003/PA/003 ALMENDRAS, ACEITE VIRGEN DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PA/016 HIDRÓXIDO DE CALCIOΔιαθέσιμο 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: White PetrolatumJP XVIII, 2021; English textPrinted p. 1501; 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
- 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: arachis oil, wool fat, cetostearyl/cetyl alcohol, chlorocresolCurrent primary excipient warnings; used as a scientific labelling reference, without claiming MAH obligations automatically apply to a compounded prescription2026-10-14