Final editorial decision
Final base-development reference — not an executable compounding protocol.
EX006 does not identify its 5% self-emulsifying silicone base. That description does not establish product selection, active content or process. The composition remains a development reference. A specific commercial implementation requires a separate identity, complete technical evidence and the manufacturer's procedure.
AEMPS states 6 calendar months below 30 °C in an opaque jar protected from moisture. This remains source information and is not assigned as an executable BUD for an unidentified base. An external silicone phase does not demonstrate low aw. Adding an active produces a finished preparation requiring its own assessment.
Required evidence
- AEMPS clarification identifying the exact silicone-base product or separately identified commercial implementation with complete composition/active fraction.
- Supplier instructions for the exact 5% base, 15% cyclomethicone, 3% glycerol, 2% NaCl and EX001 system; recorded order, temperature, addition rate and mixing.
- Actual W/Si emulsion-type, uniformity, structure, preservation and container-compatibility evidence throughout the stated period.
Closure criteria
- Uniquely identified grade with pharmaceutical suitability and demonstrated compatibility; a shared INCI or likely trade name is insufficient.
- The process and actual results satisfy prospectively approved specifications. Every change is declared an adaptation and every active-containing finished preparation has its own assessment.
Scope
Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.
Sources and references
- AEMPS FN/2003/EX/006, Emulsión A/SPDF p.2, sections 3–7
- AEMPS PN/L/FF/002/00, Elaboración de emulsionesPDF pp.3–5; §4.1, 4.4, 4.6
- 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 |
|---|---|---|
| Cyclomethicone | 15 g | — |
| Unspecified self-emulsifying silicone base | 5 g | — |
| Glycerol | 3 g | — |
| Sodium chloride | 2 g | — |
| Preserved water AEMPS EX001 | q.s. ad 100 g | — |
Prerequisite formulations
Documentation
Preparation description
Firm glossy white emulsion. [1]
Action and use
Base or auxiliary excipient for further compounding. Its BUD is not adopted unchanged after adding an active. [1]
Specifications
Firm glossy white emulsion. [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
Glycerol is miscible with water. This does not establish product microbiological stability.
Sodium Chloride: JP classifies the corresponding pure raw material as freely soluble in water.
Component of base CGR-ES-017: Propylene Glycol: JP classifies the corresponding pure raw material as miscible in water.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as very slightly soluble in water. [2], [7], [12], [13], [14], [15]
Sodium Chloride: JP classifies the corresponding pure raw material as freely soluble in water.
Component of base CGR-ES-017: Propylene Glycol: JP classifies the corresponding pure raw material as miscible in water.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as very slightly soluble in water. [2], [7], [12], [13], [14], [15]
Humidity
For the finished product the source specifies:
Opaque jar, protect from moisture, <30°C.
Glycerol is hygroscopic; limit raw-material exposure to moisture.
Component of base CGR-ES-017: Propylene glycol is hygroscopic; close its container promptly after measuring.
Component of base CGR-ES-017: Propylene Glycol: the raw material is hygroscopic according to JP. [1], [2], [11], [12], [13]
Opaque jar, protect from moisture, <30°C.
Glycerol is hygroscopic; limit raw-material exposure to moisture.
Component of base CGR-ES-017: Propylene glycol is hygroscopic; close its container promptly after measuring.
Component of base CGR-ES-017: Propylene Glycol: the raw material is hygroscopic according to JP. [1], [2], [11], [12], [13]
Temperature
For the finished product the source specifies:
Opaque jar, protect from moisture, <30°C. [1]
Opaque jar, protect from moisture, <30°C. [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
Glycerol: hazardous reaction with strong oxidising agents. [2]
Ingredient-specific information
Glycerol: clear, colourless, viscous and strongly hygroscopic liquid. It mixes with water but is practically insoluble in fixed and essential oils.
Sodium Chloride: raw-material water solubility is classified as freely soluble by JP.
Glycerol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit.
Component of base CGR-ES-017: Propylene glycol (1,2-propanediol): colourless viscous water-miscible cosolvent and humectant. A small amount does not establish adequate preservation.
Component of base CGR-ES-017: Propylene Glycol: raw-material water solubility is classified as miscible by JP.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: raw-material water solubility is classified as slightly soluble by JP.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: raw-material water solubility is classified as very slightly soluble by JP. [2], [7], [8], [11], [12], [13], [14], [15]
Sodium Chloride: raw-material water solubility is classified as freely soluble by JP.
Glycerol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit.
Component of base CGR-ES-017: Propylene glycol (1,2-propanediol): colourless viscous water-miscible cosolvent and humectant. A small amount does not establish adequate preservation.
Component of base CGR-ES-017: Propylene Glycol: raw-material water solubility is classified as miscible by JP.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: raw-material water solubility is classified as slightly soluble by JP.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: raw-material water solubility is classified as very slightly soluble by JP. [2], [7], [8], [11], [12], [13], [14], [15]
Staff protection
Risk assessment
Component of base CGR-ES-017: Propylene glycol: assess exposure from all medicines, especially in neonates, children under 5 and renal/hepatic impairment. For oral dosing: mg/kg/day = mg/mL × daily mL ÷ body weight in kg.
Reference batch: 100 g. First ingredient: Cyclomethicone, 15 g. Independently check chemical form, units and every scale conversion before weighing.
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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], [11], [12], [17], [19]
Reference batch: 100 g. First ingredient: Cyclomethicone, 15 g. Independently check chemical form, units and every scale conversion before weighing.
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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], [11], [12], [17], [19]
Compounding conditions
The corresponding AEMPS SOP specifies room temperature 25 ± 5°C and relative humidity ≤60%, unless the particular formula requires otherwise. This is the work environment, not processing or storage temperature.
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment. [1], [4]
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment. [1], [4]
BUD rationale
AEMPS states 6 calendar months below 30 °C in an opaque jar protected from moisture. This remains source information and is not assigned as an executable BUD for an unidentified base. An external silicone phase does not demonstrate low aw. Adding an active produces a finished preparation requiring its own assessment. [1], [4], [20]
Prerequisites
AEMPS EX001 Preserved water: CGR-ES-018 [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
EX006 does not identify its 5% self-emulsifying silicone base. That description does not establish product selection, active content or process. The composition remains a development reference. A specific commercial implementation requires a separate identity, complete technical evidence and the manufacturer's procedure. [1], [4], [20]
Observations
The source does not adequately identify the 5 g self-emulsifying silicone base. Execution requires a specific commercial grade/composition, active emulsifier content and a verified process for the formula’s 15% cyclomethicone and electrolytes. An INCI name alone does not establish equivalence.
Require named grade, complete composition/active emulsifier fraction and compatibility data for the specified water, cyclomethicone and electrolytes. Verify emulsion type, structure, uniformity, preservation and container compatibility. Shared INCI or another mixer’s rpm is insufficient. [1], [19]
Require named grade, complete composition/active emulsifier fraction and compatibility data for the specified water, cyclomethicone and electrolytes. Verify emulsion type, structure, uniformity, preservation and container compatibility. Shared INCI or another mixer’s rpm is insufficient. [1], [19]
Container and packaging
Opaque jar, protect from moisture, <30°C. [1]
Quality control
Firm glossy white emulsion.
Additional tests from the referenced SOP:
Appearance and mass. For batches: spreadability PN/CP/003, emulsion type PN/CP/002, pH of O/W emulsions PN/CP/001 and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.
Spreadability PN/CP/003: fixed sample quantity between glass plates, with locally defined successive loads and times; measure two diameters and compare area against load. Temperature variation of ±0.5°C is suggested. The source gives no universal acceptance limit; establish it locally.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [4], [5], [6], [8], [19]
Additional tests from the referenced SOP:
Appearance and mass. For batches: spreadability PN/CP/003, emulsion type PN/CP/002, pH of O/W emulsions PN/CP/001 and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.
Spreadability PN/CP/003: fixed sample quantity between glass plates, with locally defined successive loads and times; measure two diameters and compare area against load. Temperature variation of ±0.5°C is suggested. The source gives no universal acceptance limit; establish it locally.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [4], [5], [6], [8], [19]
Storage
Opaque jar, protect from moisture, <30°C. [1]
Dispensing
final_decision
Final base-development reference — not an executable compounding protocol.
EX006 does not identify its 5% self-emulsifying silicone base. That description does not establish product selection, active content or process. The composition remains a development reference. A specific commercial implementation requires a separate identity, complete technical evidence and the manufacturer's procedure.
AEMPS states 6 calendar months below 30 °C in an opaque jar protected from moisture. This remains source information and is not assigned as an executable BUD for an unidentified base. An external silicone phase does not demonstrate low aw. Adding an active produces a finished preparation requiring its own assessment. [1], [4], [20]
EX006 does not identify its 5% self-emulsifying silicone base. That description does not establish product selection, active content or process. The composition remains a development reference. A specific commercial implementation requires a separate identity, complete technical evidence and the manufacturer's procedure.
AEMPS states 6 calendar months below 30 °C in an opaque jar protected from moisture. This remains source information and is not assigned as an executable BUD for an unidentified base. An external silicone phase does not demonstrate low aw. Adding an active produces a finished preparation requiring its own assessment. [1], [4], [20]
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- FN/2003/EX/006 EMULSIÓN A/SFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/PA/013 GLICEROLΔιαθέσιμο 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
- PN/L/FF/002/00 ELABORACIÓN DE EMULSIONESΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- PN/L/CP/001/00 DETERMINACIÓN DE PHΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5qc method2026-09-10
- PN/L/CP/003/00 DETERMINACIÓN DE EXTENSIBILIDADΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6qc method2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Sodium ChlorideJP XVIII, 2021; English textPrinted p. 1702; Description; Containers and storageraw-material monograph2026-09-12
- FDA — Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolMay 2023, revision 1Recommendations; section on pharmacy compoundingraw material quality2026-09-12
- 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
- EMA — Questions and answers on propylene glycol used as an excipient, EMA/CHMP/704195/20139 October 2017Sections 1–3 and annexingredient facts2026-09-12
- FN/2003/EX/025 SOLUCIÓN CONCENTRADA DE HIDROXIBENZOATOS2003PDF pp. 2master formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Propylene GlycolJP XVIII, 2021; English textPrinted p. 1600; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Methyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1343; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Propyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1601; Description; Containers and storageraw-material monograph2026-09-12
- 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> 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