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CGR-ES-015 / EDITION 10.0

Urea cream 15% AEMPS

Cream · Spain · AEMPS

2026-10-14Final reference document

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 10.0Record editorial review date: 2026-10-14

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Final editorial decision

Final development reference — not an executable patient-compounding protocol.

PO/029 requires emulsification without heating, whereas its EX010 vehicle requires both phases to be heated to 70–75 °C. This edition does not combine these conflicting instructions into an unsupported recipe. Another commercial vehicle or incorporation sequence is a separate adaptation requiring its own documentation.

AEMPS states 3 calendar months in a well-closed opaque jar below 25 °C. This is recorded as the source instruction and is not assigned as a production BUD while the exact process is unsupported. No new stability study or aw measurement is claimed.

Required evidence

  • AEMPS clarification or separate development resolving PO029 no-heating versus EX010 70–75 °C.
  • Identified EX010 non-ionic self-emulsifying grade with complete technical evidence and supplier instructions.
  • Actual exact-formula study of urea/degradation, pH, crystallization, uniformity, emulsion structure and preservation in an opaque jar.

Closure criteria

  • Clear achievable addition sequence and urea temperature exposure, without undeclared solvent or a changed vehicle labelled as unchanged source monograph.
  • Results satisfy justified prospectively approved limits throughout the adopted period below 25 °C; actual batch release is signed.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. AEMPS FN/2003/PO/029, Urea, crema al 15% dePDF p.2, sections 3–7; p.3 patient leaflet
  2. AEMPS FN/2003/EX/010, Emulsión O/A no iónica 1PDF p.2, sections 3–4
  3. AEMPS PN/L/FF/002/00, Elaboración de emulsionesPDF pp.3–5; §4.1, 4.4, 4.6
  4. 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

IngredientSource quantityScaled quantity
Urea15 g—
Non-ionic O/W emulsion 1 AEMPSq.s. ad 100 g—

Prerequisite formulations

Documentation

Preparation description
White glossy cream. [1]
Action and use
Hydrating/keratolytic action of urea. [1]
Specifications
White glossy cream. [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
Urea is water-soluble.
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], [8], [9], [10]
Humidity
Urea is hygroscopic.
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. [2], [6], [7], [8]
Temperature
For the finished product the source specifies:
Opaque jar, well closed, <25 °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
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
Identity and weighing basis:
• Urea: 15 g.
• Non-ionic O/W emulsion 1 AEMPS: q.s. ad 100 g.
The specified chemical forms/grades belong to the exact source formula.
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. [1], [6], [7], [8], [9], [10]
Staff protection
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. [1], [3], [4]
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: Urea, 15 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. [1], [6], [7], [12], [14]
Compounding conditions
Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. [1], [4]
BUD rationale
AEMPS states 3 calendar months in a well-closed opaque jar below 25 °C. This is recorded as the source instruction and is not assigned as a production BUD while the exact process is unsupported. No new stability study or aw measurement is claimed. [1], [15], [16], [17]
Prerequisites
FN/2003/EX/010 EMULSIÓN O/A NO IÓNICA 1: CGR-ES-019 [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
PO/029 requires emulsification without heating, whereas its EX010 vehicle requires both phases to be heated to 70–75 °C. This edition does not combine these conflicting instructions into an unsupported recipe. Another commercial vehicle or incorporation sequence is a separate adaptation requiring its own documentation. [1], [15], [16], [17]
Observations
AEMPS requires urea incorporation without heating while EX010 uses hot emulsification. An executable combined protocol for this exact composition was not established. Confirm incorporation sequence, homogeneity, pH and stability before patient preparation. Changing the base creates a different formula.
Specify urea incorporation without violating the no-heating instruction. Study assay/degradation with a suitable method, pH, crystallisation, uniformity and preservation in exact EX010. A general hot process for other urea creams does not validate this formula.
The current official FN/2003/PO/029 still requires dissolving urea in the aqueous phase and emulsifying without heating. Do not treat adding it to hot EX010, or switching base, as the same source procedure. Support an executable cold process for the actual materials or obtain AEMPS clarification. [1], [14]
Container and packaging
Opaque jar, well closed, <25 °C. [1]
Quality control
White glossy cream.
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], [14]
Storage
Opaque jar, well closed, <25 °C. [1]
Dispensing
This entry does not generate a label or authorise patient dispensing. Consult its final decision and implementation criteria. [1], [15], [16], [17]
Labelling
No dispensing label is issued by this entry. [1], [15], [16], [17]
final_decision
Final development reference — not an executable patient-compounding protocol.

PO/029 requires emulsification without heating, whereas its EX010 vehicle requires both phases to be heated to 70–75 °C. This edition does not combine these conflicting instructions into an unsupported recipe. Another commercial vehicle or incorporation sequence is a separate adaptation requiring its own documentation.

AEMPS states 3 calendar months in a well-closed opaque jar below 25 °C. This is recorded as the source instruction and is not assigned as a production BUD while the exact process is unsupported. No new stability study or aw measurement is claimed. [1], [15], [16], [17]

Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.

Sources and references

  1. FN/2003/PO/029 UREA, CREMA AL 15% DE2003PDF pp. 1–3master formula2026-10-14
  2. FN/2003/PA/039 UREAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
  3. PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
  4. ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
  5. 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
  6. EMA — Questions and answers on propylene glycol used as an excipient, EMA/CHMP/704195/20139 October 2017Sections 1–3 and annexingredient facts2026-09-12
  7. FN/2003/EX/025 SOLUCIÓN CONCENTRADA DE HIDROXIBENZOATOS2003PDF pp. 2master formula2026-09-10
  8. MHLW — Japanese Pharmacopoeia XVIII: Propylene GlycolJP XVIII, 2021; English textPrinted p. 1600; Description; Containers and storageraw-material monograph2026-09-12
  9. MHLW — Japanese Pharmacopoeia XVIII: Methyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1343; Description; Containers and storageraw-material monograph2026-09-12
  10. MHLW — Japanese Pharmacopoeia XVIII: Propyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1601; Description; Containers and storageraw-material monograph2026-09-12
  11. 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
  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
  13. 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
  14. 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
  15. 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
  16. AEMPS FN/2003/EX/010, Emulsión O/A no iónica 1PDF p.2, sections 3–4Targeted prerequisite / publication decision; not batch result2026-10-14
  17. AEMPS PN/L/FF/002/00, Elaboración de emulsionesPDF pp.3–5; §4.1, 4.4, 4.6Targeted prerequisite / publication decision; not batch result2026-10-14